WO2008046019A1 - Light delivery apparatus and methods for illuminating internal tissues - Google Patents

Light delivery apparatus and methods for illuminating internal tissues Download PDF

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Publication number
WO2008046019A1
WO2008046019A1 PCT/US2007/081147 US2007081147W WO2008046019A1 WO 2008046019 A1 WO2008046019 A1 WO 2008046019A1 US 2007081147 W US2007081147 W US 2007081147W WO 2008046019 A1 WO2008046019 A1 WO 2008046019A1
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WO
WIPO (PCT)
Prior art keywords
illumination device
light
configuration
tissue
delivery apparatus
Prior art date
Application number
PCT/US2007/081147
Other languages
French (fr)
Inventor
James C. Chen
Erik Ross Haugaard
Louis Barnard Barnard
Original Assignee
Light Sciences Oncology, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Light Sciences Oncology, Inc. filed Critical Light Sciences Oncology, Inc.
Publication of WO2008046019A1 publication Critical patent/WO2008046019A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/06Radiation therapy using light
    • A61N5/0601Apparatus for use inside the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/06Radiation therapy using light
    • A61N5/0613Apparatus adapted for a specific treatment
    • A61N5/062Photodynamic therapy, i.e. excitation of an agent
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00982Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B2018/1807Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using light other than laser radiation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B2018/208Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser with multiple treatment beams not sharing a common path, e.g. non-axial or parallel
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/06Radiation therapy using light
    • A61N2005/0635Radiation therapy using light characterised by the body area to be irradiated
    • A61N2005/0643Applicators, probes irradiating specific body areas in close proximity
    • A61N2005/0645Applicators worn by the patient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/06Radiation therapy using light
    • A61N2005/065Light sources therefor
    • A61N2005/0651Diodes
    • A61N2005/0652Arrays of diodes

Definitions

  • the present invention relates generally to a light delivery apparatus usable for medical treatment, such as light therapy for the treatment of internal tissues.
  • Obesity is often caused by an excessively high caloric intake which leads to accumulation of surplus fat and various types of diseases (e.g., diabetes). Obesity can lead to various problems ranging from a loss of mobility to causing a shortened lifespan.
  • Various weight loss techniques, such as dieting, are often used by people suffering from obesity. Even people of healthy weight may wish to control their weight for health and cosmetic reasons.
  • Appetite suppression can be used for weight control.
  • Drugs e.g., centrally-acting neuro-stimulants like cocaine, methamphetamine hydrochloride, dextroamphetamine sulfate, and other derivatives of the amphetamine molecule
  • drugs typically are only effective for a short period of time and may have inherent unwanted side effects.
  • Invasive medical procedures such as liposuction, are often used to remove fat but require significant periods of recovery time. Invasive procedures further subject the patient to risks of infection and bleeding, anesthesia risks, and other post-surgical complications.
  • liposuction involves the introduction of probes around 5 mm in diameter through holes in the skin to remove adipose tissue. Unfortunately, liposuction often causes permanent depressions in the zone of insertion of the probe, excessive bleeding, and nonselective removal of fat cells and the cells of the stroma. The permanent depressions can result in an unnatural skin appearance.
  • Intra-abdominal fat such as omentum fat
  • omentum fat can surround and protect the human bowels.
  • perforating the abdomen with a liposuction cannula, for example, to reach the omentum fat can cause an infection, such as peritonitis.
  • physically removing omentum fat can damage the omentum thereby increasing the overall recovery period.
  • the embodiments described herein are generally related to a treatment system usable for treating one or more internal target sites of a subject.
  • a light delivery system can treat target sites at different depths and positions in an individual's body.
  • the target sites can include, without limitation, diseased tissues (e.g., cancerous cells), interstitial tissues, epithelial tissues, connective tissues (e.g., blood, cartilage, and/or bone), nerve tissues, or other regions of interest.
  • the target site can be treated with or without using medicaments (e.g., treatment agents or photosensitive agents).
  • the disclosed embodiments can treat at least a portion of the omentum to destroy omentum fat, with or without utilizing photosensitive agents (e.g., photo- reactive agents), or other energy activated agents.
  • a light delivery apparatus of the treatment system can perform different types of light therapies.
  • the term "light therapy” and its variants are to be construed broadly to include, without limitation, methods of treating a patient with light applied externally and/or internally.
  • Light therapy can be used to treat various types of medical conditions (e.g., proliferative diseases including cancer) and cosmetic conditions. In some embodiments, these procedures are performed without physically contacting the target tissues, thereby minimizing trauma to the subject and reducing recovery periods. Because minimally invasive techniques can be used, the light delivery apparatus can reduce the risk of infection or internal bleeding. Unlike surgical tissue removal producers (e.g., liposuction), tissue treated by light therapy can be destroyed and reabsorbed naturally by the body.
  • the light delivery apparatuses can selectively treat specific target tissues, even remote subcutaneous tissues. A localized region of target tissue can be treated without treating or otherwise significantly affecting non-targeted tissues, thereby providing improved treatment flexibility in administering a particular treatment.
  • the light delivery apparatuses can be used for diagnostic, therapeutic, cosmetic, and/or other types of procedures.
  • the light delivery apparatus can emit light with a wavelength selected to cause the photo-reactive agent to fluoresce as a means to acquire information about the targeted cells without damaging the targeted cells.
  • the wavelength of light delivered to the targeted cells treated with the photo-reactive agent causes the agent to undergo a photochemical reaction with oxygen in the localized targeted cells, to yield free radical species (such as singlet oxygen), which causes localized cell destruction (e.g., cell lysis), size reduction, or necrosis, for example.
  • Light can be delivered to the target tissue without physically contacting the target tissue.
  • the light delivery apparatus can treat deposits of fat, which can cause a particular area of the patient's body to appear disproportionate. These localized fat deposits may not be sufficiently reduced in size through dieting, exercise, and other traditional weight loss techniques.
  • the light delivery apparatus can treat these fat deposits resulting in a more proportionate body.
  • the fat tissue is destroyed or reduced in size, and if the skin has enough elasticity, the skin can achieve a naturally appearing smooth contour. If the skin in proximity to the treatment site is unsuitably inelastic, one or more skin tightening procedures may be performed to achieve the desired overall appearance.
  • Various access techniques can be used to deliver the light delivery apparatus.
  • Open procedures, semi-open procedures, laparoscopic procedures, and minimally invasive procedures can provide suitable access to the target site.
  • Known conventional surgical instruments e.g., sizing rings, balloons, calipers, gauges, delivery sheaths, cannulas, and the like
  • the access techniques and procedures can be performed by the surgeon and/or a robotic device, such as robotic systems used for performing minimally invasive heart surgery.
  • robotic systems used for performing minimally invasive heart surgery.
  • the light delivery apparatus has an illumination device that is folded, furled, rolled-up, or otherwise in a low profile arrangement when in a collapsed configuration.
  • the illumination device can be unfolded, unfurled, unrolled, expanded outwardly, or otherwise enlarged to assume an expanded configuration for emitting light rays suitable for treating target tissue.
  • the light delivery apparatus is rotationally locked thereby ensuring proper positioning during the illumination procedure. The illumination device can thus be easily positioned and aimed at the target tissue.
  • the treatment agent for use with the light delivery apparatus can be administered locally, systemically, orally, or by injection, which may be intravenous, subcutaneous, intramuscular, or intraperitoneal.
  • the treatment agent also can be administered externally or topically via patches or implants.
  • Visceral fat such as panniculus adipose tissue
  • the reduction of this visceral fat may improve a patient's condition. If a person is suffering from type Il diabetes, for example, the reduction of visceral fat may reverse or improve insulin resistance, diabetes syndrome, and/or metabolic syndrome. This can lead to reduced medical costs associated with diabetes.
  • the frequency and likelihood of complications (e.g., heart disease, renal failure, foot ulcers, and diabetic retinopathy, and the like) of diabetes can also be reduced or eliminated.
  • the light delivery apparatus can destroy fat cells to reduce the amount of visceral fat.
  • the treated adipose cells may break down (e.g., immediately or gradually over an extended period of time) and are subsequently absorbed by the patient's body.
  • the amount of visceral fat can be reduced in a controller manner.
  • This procedure can be performed any number of times at different locations until the desired amount of fat has been eliminated.
  • visceral fat can be removed until achieving a noticeable improvement in insulin resistance.
  • fat at other target sites can also be treated in a similar manner.
  • fat deposits can be precisely destroyed or eliminated for health or cosmetic reasons.
  • the system may have a low profile, the system can be delivered to remote locations using minimally invasive techniques.
  • a method of treating visceral adipose tissue includes providing a catheter having a distal end with a plurality of light sources movable with respect to one another. The distal end is sufficiently flexible for placement within a patient. The distal end of the catheter is advanced through the patient until the distal end is proximate to the visceral adipose tissue. The visceral adipose tissue is illuminated with the plurality of light sources. Illuminating the visceral adipose tissue with the plurality of light sources includes activating a treatment agent in the visceral adipose tissue so as to destroy at least a portion of the adipose tissue. The treatment can be repeated to destroy a desired amount of tissue.
  • a light delivery apparatus for treating a subject comprises a deployable illumination device.
  • the deployable illumination device has at least one light source capable of emitting light that activates a therapeutically effective amount of a treatment agent in target tissue.
  • the light delivery apparatus also has a main body coupled to the illumination device.
  • the main body is configured to carry the illumination device to a location near the target tissue.
  • the main body can be rod, catheter body, or other rigid or flexible structure.
  • a light delivery apparatus for treating a subject comprises a light emitting tip.
  • the light emitting tip is movable between a low profile configuration and an expanded illumination configuration.
  • the therapy tip also has at least one light source or optical fiber, which is positioned to deliver light to a target site in the subject when the tip is in the illumination configuration.
  • a method of treating target tissue of a subject comprises advancing an illumination device into the subject.
  • the illumination device has at least one light source adapted to emit light capable of activating a treatment agent.
  • a space between a first layer of tissue and a second layer of tissue in the patient is insufflated.
  • the illumination device is positioned in the space, and the first layer of tissue is illuminated with light from the at least one light source.
  • a light system to perform a method of treating target tissue of a subject.
  • the method comprises advancing an illumination device into the subject.
  • the illumination device has at least one light source adapted to emit light capable of activating a treatment agent.
  • a space between a first layer of tissue and a second layer of tissue in the patient is insufflated.
  • the illumination device is positioned in the space, and the first layer of tissue is illuminated with light from the at least one light source.
  • a light treatment system for treating target tissue of a subject has at least one light source that emits light capable of activating a treatment agent.
  • the light treatment system insufflates a space between a first layer of tissue and a second layer of tissue in the subject.
  • the illumination device is positioned in the space, and the first layer of tissue is illuminated with light from the at least one light source.
  • a light delivery apparatus includes an illumination device dimensioned for placement in a body of the subject.
  • the illumination device has a first preset configuration and a second preset configuration.
  • a plurality of light sources is coupled to the illumination device and become exposed when the device moves from the first configuration to the second configuration.
  • a light delivery apparatus for treating a subject includes an illumination device dimensioned for placement in a cavity in a body of the subject.
  • the illumination device has a first preset configuration and a second preset configuration.
  • a plurality of light sources is coupled to the illumination device.
  • An outermost pair of the light sources defines a first transverse width when the illumination device is in the first configuration and an outermost pair of the light sources defines a second transverse width greater than the first transverse width when the illumination device is in the second configuration.
  • the illumination device has a long axis, and the light sources are moved away from the long axis as the illumination device moves from the first preset configuration towards the second preset configuration.
  • a light delivery apparatus can be used to treat a target site of tissue to promote tissue growth (e.g., cell division, cell growth or enlargement, etc.), increase the rate of healing, improve circulation, reduce or minimize pain, relieve stiffness, and the like.
  • the light delivery apparatus can illuminate different types of tissue, such as muscle, bone, cartilage, or other suitable tissue, without using a treatment agent.
  • One or more light sources of the light delivery apparatus can be adapted to emit light with near-infrared or infrared wavelengths. This light itself can cause tissue growth.
  • the light delivery apparatus can be used in combination with growth enhancers, growth factors, and the like.
  • the light delivery apparatus can also be used to destroy tissue by emitting energy that causes cell destruction.
  • One or more energy sources of the light delivery apparatus can be activated to generate enough heat for cell destruction. If the energy sources are LEDs, the LEDs, when activated, can generate a sufficient amount of heat to cause tissue damage. In other embodiments, the energy sources can emit ultraviolet light that destroys the target cells. Such embodiments are especially well suited for destroying a thin layer of tissue without using a treatment agent or damaging an underlying layer of tissue.
  • a light delivery system for performing light therapy on a subject.
  • the light delivery system includes an introducer adapted for placement in an opening in tissue of the subject and a deployable illumination device.
  • the deployable illumination device has a plurality of light sources or optical fibers capable of emitting light.
  • the illumination device is movable from a collapsed configuration to an expanded configuration to move the plurality of light sources into a deployed configuration.
  • the illumination device, in the collapsed configuration has a first transverse width and the illumination device, in the expanded configuration, has a second transverse width substantially greater than the first transverse width.
  • the second transverse width can be equal to or greater than 2 times the first transverse width.
  • the second transverse width can be equal to or greater than 3 times the first transverse width.
  • the system further comprises an elongate main body coupled to the illumination device.
  • the elongate main body is configured to carry the illumination device along a lumen of the introducer into a space adjacent target tissue of the subject. After passing through the lumen closely surrounding the illumination device, the illumination is expanded outwardly.
  • the illumination device has a long axis.
  • the light sources are moved away from the long axis as the illumination device moves from the first configuration towards the second configuration.
  • the light delivery system includes an insufflating system.
  • the insufflating system may include a pressurization device and a fluid line coupled to the pressurization device to provide fluid communication between the cavity and the pressurization device.
  • the pressurization device is adapted to insufflate the cavity when activated.
  • Figure 1 is a side elevational view of a light delivery apparatus extending through an introducer, where an illumination device of the light delivery apparatus is positioned within a body cavity of a subject.
  • Figure 2A is a side elevational view of a light delivery apparatus with an illumination device in a collapsed configuration, in accordance with one illustrated embodiment.
  • Figure 2B is a side elevational view of the light delivery apparatus of Figure 2A where the illumination device is in an expanded configuration.
  • Figure 3A is a side elevational view of an introducer, in accordance with one illustrated embodiment.
  • Figure 3B is a longitudinal cross-sectional view of the introducer of Figure 3A.
  • Figure 4 is a side elevational view of a light delivery apparatus positioned outside of a patient, in accordance with one illustrated embodiment.
  • Figure 5 is a side elevational view of the illumination device of the light delivery apparatus positioned within an introducer.
  • Figure 6 is a side elevational view of the illumination device positioned in a body cavity.
  • Figure 7 is a perspective view of a light delivery apparatus, in accordance with another embodiment.
  • Figure 8 is a perspective view of an illumination device of the light delivery apparatus of Figure 7, where the illumination device is in a deployment position.
  • Figure 9 is a perspective view of the illumination device of the light delivery apparatus of Figure 7, where the illumination device is in an expanded configuration.
  • Figure 10 is a front elevational view of the expanded illumination device of the light delivery apparatus of Figure 7.
  • Figures 11A and 11 B are side elevational views of a main body of the light delivery apparatus of Figure 7 has a movable mounting tip, in accordance with one illustrated embodiment.
  • Figures 12A to 12D are top elevational views of sheet assemblies.
  • Figure 13 is a perspective view of an illumination device in a collapsed configuration, in accordance with one illustrated embodiment.
  • Figure 14 is a perspective view ofthe illumination device of Figure 13 in an expanded configuration.
  • Figure 15 is a perspective view of an illumination device in a collapsed configuration, in accordance with one illustrated embodiment.
  • Figure 16 is a perspective view ofthe illumination device of Figure 15 in a partially expanded configuration.
  • Figure 17 is a perspective view of the illumination device of Figure 15 in a fully expanded configuration.
  • Figure 18 is a perspective view of a light delivery apparatus with a collapsed illumination device in a low profile position, in accordance with one illustrated embodiment.
  • Figure 19 is a perspective view ofthe illumination device of Figure 18 in a deployment position.
  • Figure 20 is a perspective view ofthe illumination device of Figure 18 in an expanded configuration.
  • Figure 21 is a side elevational view of an actuating assembly of the light delivery apparatus of Figure 18, where the illumination device is in a low profile position.
  • Figure 22 is a side elevational view of the actuating assembly of
  • Figure 21 where the illumination device is in a deployment position.
  • Figure 23 is a side elevational view of a light delivery apparatus having an illumination device in a collapsed configuration.
  • Figure 24 is a side elevational view of the light delivery apparatus of Figure 23, where the illumination device is in an expanded configuration.
  • Figure 25 is a bottom elevational view of the light delivery apparatus of Figure 23.
  • Figure 26 is a side elevational view of the illumination device of the light delivery apparatus positioned within a body cavity.
  • Figure 27 is a side elevational view of a light delivery apparatus, where an inflatable member is positioned within a body cavity and surrounds a deployed illumination device.
  • FIG. 1 shows a treatment system 90 including a light delivery apparatus 100 for performing light therapy.
  • the light delivery apparatus 100 includes a deployable illumination device 110 and an elongate main body 112 coupled to the illumination device 110.
  • the illumination device 110 is positioned within an internal space or cavity 114 between an omentum 120 and an abdominal wall 122. When activated, the illumination device 110 emits light rays towards the omentum 120.
  • This light can interact with one or more treatment agents to photo- activate or photo-excite target tissue 130 ⁇ e.g., intra-abdominal fat) in or around the omentum 120.
  • the light can therefore cause localized cell destruction, size reduction, and/or necrosis of intra-abdominal fat resulting in weight loss.
  • Intra-abdominal fat including mesenteric adipose tissue and omental adipose tissue
  • This tissue may contribute to the onset of diseases, including metabolic disorders (e.g., arteriosclerosis, diabetes, and/or hyperlipemia) and cardiac vessel disorders.
  • the emitted light can destroy, reduce in size, or otherwise treat the adipose tissue such that these diseases can be reversed or otherwise improved.
  • the light delivery apparatus 100 can treat adipose tissue without physically contacting the adipose tissue or tissue proximate the adipose tissue, thus minimizing trauma to the patient.
  • the illumination device 110 can be activated while being spaced from both the omentum 120 and abdominal wall 122. Additionally, the illumination device 110 is relatively small for convenient navigation within the cavity 114 but capable of illuminating a relatively large area of target tissue.
  • the illumination device 110 has an array of light sources 140 for emitting light.
  • the light sources 140 can uniformly illuminate the target tissue 130 to ensure somewhat homogenous activation of the treatment agent therein.
  • the target tissue 130 may be subjected to at least one wavelength of light that is approximately close to, if not the equivalent to, at least one excitation wavelength of the treatment agent, according to some embodiments. It is understood that even if one cell is targeted, it is possible that other cells in the vicinity of the targeted cell may also be subjected to light emitted from the one or more light sources.
  • the illumination device 110 can be expanded or contracted during, before, and/or after the light sources 140 are activated. Thus, the light field can be adjusted by altering the configuration of the illumination device 110.
  • An insufflating system 141 can form and size the internal cavity 114 via an expansion process.
  • the cavity 114 is dimensioned to accommodate the illumination device 110 before, during, and/or after the expansion process. Because the illumination device 110 has a low profile in its collapsed configuration (as discussed in connection with Figures 2A and 2B), the illumination device 110 can be passed into the cavity via a narrow hole in the abdominal wall 122 and then expanded within the cavity 114.
  • the insufflating system 141 includes a pressurization device 146 in fluid communication with the cavity 114 via a fluid line 150.
  • the pressurization device 146 delivers a liquid/gas through the line 150 to an introducer 210, which in turn delivers the liquid/gas into the cavity 114.
  • the liquid/gas fills and expands the cavity 114.
  • the volume of the cavity 114 can increase at least 50%, 100%, 200%, 500%, or ranges encompassing such percentages, by using the insufflating system 141.
  • Figures 2A and 2B show the light delivery apparatus 100 including the illumination device 110, a control assembly 170, and the main body 112 extending therebetween.
  • the illumination device 110 is movable between a collapsed configuration (Figure 2A) and an expanded configuration ( Figure 2B).
  • the collapsed illumination device 110 has a relatively low profile for delivery through small openings.
  • the array of light sources 140 can be aimed distally, as shown in Figure 1. Accordingly, the sources 140 can illuminate a target region of the omentum 120 without illuminating collateral tissue.
  • the illumination device 110 protects the abdominal wall 122 from inadvertent light therapy.
  • some emitted light in some instances, may be reflected through the cavity 114 to collateral tissue; however, the amount of activated treatment agent in non- targeted tissue can be kept at or below an acceptable level.
  • an outermost pair of light sources When the illumination device 110 is collapsed, an outermost pair of light sources defines a first transverse width T 1 (Figure 2A). When the illumination device 110 is in the expanded configuration, an outermost pair of light sources defines a second transverse width T 2 ( Figure 6). The second transverse width T 2 is greater than the first transverse width T 1 .
  • the outermost pairs of light sources when the illumination device is in the collapsed configuration and expanded configuration, can be the same pair of lights or a different pair of lights.
  • the illustrated illumination device 110 of Figure 2B includes a hub
  • the elongate struts 180a, 180b, 180c have distal ends 181a, 181b,
  • proximal ends 183a, 183b, 183c of the respective elongate struts 180a, 180b, 180c are coupled to the hub 182.
  • Hinges, pivots, flexible connectors, or other suitable structures can rotatably couple the proximal ends 183a, 183b, 183c to the hub 182.
  • Each of the elongate struts 180a, 180b, 180c can carry at least one light source 140.
  • the light sources 140 can be LEDs (such as edge emitting LEDs, surface emitting LEDs, super luminescent LEDs), laser diodes, and the like.
  • the illustrated light sources can emit appropriate wavelength(s) or waveband(s) suitable for treating the patient, with or without using a treatment agent, as noted above. If a treatment agent ⁇ e.g., a photo-reactive or photosensitive agent) is utilized, the light sources may emit radiation wavelength(s) or waveband(s) that correspond with, or at least overlap with, the wavelength(s) or waveband(s) that excite or otherwise activate the agent.
  • Photosensitive agents can often have one or more absorption wavelengths or wavebands that excite them to produce substances which damage, destroy, or otherwise treat target tissues of the patient. The photosensitive agents and light sources can be selected to achieve the desired interaction.
  • the light sources 140 can be configured to emit light having one or more wavelengths in the red spectrum and/or infrared spectrum.
  • the sources 140 can emit light, for example, having a wavelength or waveband in the range from about 400 nanometers to about 1 ,000 nanometers.
  • the light sources 140 emit a wavelength or waveband in the range from about 600 nanometers to about 800 nanometers.
  • the light sources emit a wavelength or waveband in the range from about 600 nanometers to about 700 nanometers.
  • the light sources emit radiation with a peak wavelength of 664 nanometers plus or minus 5 nanometers.
  • the light sources 140 can emit the same or similar wavelength or waveband. However, light sources 140 having different wavelengths or wavebands can be used to provide varying outputs. These light sources 140 can be activated simultaneously or at different times depending on the desired treatment.
  • each of the elongate struts 180a, 180b, 180c carries three light sources 140. Any number of light sources can be coupled to each of the struts 180a, 180b, 180c. The number, types, and positions of the light sources 140 can be selected to produce evenly or unevenly distributed light rays.
  • the illumination device 110 of Figures 2A and 2B can be self- expanding for convenient deployment.
  • the struts 180a, 18Ob 1 180c are biased radially outward.
  • the struts 180a, 180b, 180c are radially restrained to inhibit or limit self-expansion.
  • the struts 180a, 180b, 180c rotate outwardly to their expanded configurations.
  • the illumination device 110 can be passed through a lumen of a delivery catheter.
  • the lumen walls can restrain the struts 180a, 180b, 180c until the illumination device 110 delivered out of the catheter.
  • the collapsed illumination device 110 self-expands to its enlarged cross-section under its own bias following delivery through an introducer.
  • the self-expanding device 110 can be made, in whole or in part, one or more shape memory materials, which can move the illumination device 110 between the collapsed and expanded configuration when activated.
  • the shape memory material may include, for example, a shape memory alloy (e.g., NiTi), a shape memory polymer, ferromagnetic material, or other material. These materials can be transformed from a first preset configuration to a second preset configuration when activated.
  • the shape memory material can be activated by an external energy source (e.g., an ultrasound energy source, thermal energy source, etc.), internal heating elements, and the like.
  • an articulatable junction 200 connects the elongate struts 180a, 180b, 180c to the hub 182 and can comprise at least one shape memory material. After the collapsed illumination device 110 is positioned within the cavity 114, the junction 200 is activated to move the shape memory material to a preset or memorized shape to bias the elongated struts 180a, 180b, 180c towards their expanded configurations.
  • the illumination device 110 may be expanded using any of a variety of expansion techniques involving enlargement structures (such as an inflatable balloon), mechanical expansion means (such as a pullwire assembly), and the like. It is contemplated that shape memory materials can be used in combination with these expansion techniques.
  • the main body 112 can be used to steer and position the illumination device 110.
  • the main body 112 can translate and rotate the illumination device 110.
  • the properties of the main body 112 can be selected to maintain angular displacement or bending at or below a desired level.
  • the light delivery apparatus 100 can be readily rotated and translated in situ.
  • the main body 112 can include one or more wires, electrical connectors, or circuitry to provide power to the light sources 140.
  • a controller 170 commands the array of light sources 140. Each of the light sources 140 can be selectively controlled to obtain a desired light field.
  • the controller 170 can accurately control which light sources 140 are activated, the amount of power supplied to the light sources 140, and time period or sequence of activation.
  • the controller 170 includes a control input 171 and a power supply 173 (shown in phantom in Figure 2B) for powering the light sources 140.
  • the control input 171 is used to select the amount of radiant energy emitted by the light sources 140.
  • the illustrated power supply 173 is an internal battery, such as a lithium battery, that powers the light delivery apparatus 100.
  • the light delivery apparatus 100 is powered by an AC power source, such as an electrical outlet typically found at a hospital, medical facility, or other suitable location for performing light therapy.
  • the controller 170 can include a power cord connectable to the AC power source. Accordingly, various types of internal and/or external power sources can power the light delivery apparatus 100.
  • the control input 171 can control the length, number, and/or intensity of the light stimulation cycles.
  • the control input 171 can be a dial (e.g., an analog dial), but other types of input devices may be suitable for commanding the light delivery apparatus 100.
  • the control input 171 can be a digital input device, for example. Thus, digital or analog input devices can be used.
  • the controller 170 can have a closed loop system, whereby the power to the sources 140 is controlled based upon feedback signals from one or more sensors (e.g., a sensor 175 of Figure 1) configured to detect and transmit (or send) one or more signals indicative of temperature, pressure, or any other measurable parameters of interest. Based on those readings, the controller 170 can then adjust the output from the sources 140.
  • the apparatus 100 can be an open loop system wherein the amount of stimulation produced by the light sources 140 is set by user input.
  • the sources 140 may be set to a fixed power mode by utilizing the control input 171. It is contemplated that the apparatus 100 can be switched between a closed and open loop system.
  • the sensor 175 of Figure 1 can be a temperature sensor used to ensure that the temperature of the person's tissue is maintained at an acceptable level.
  • the sensor 175 can comprise, without limitation, one or more thermocouples, pyrometers, and the like. Other types of sensors can also be used.
  • Figures 3A and 3B show an introducer 210 of the treatment system 90 for placement in a hole or opening 220 in the abdominal wall 122 (see Figure 1).
  • the introducer 210 has a main body 211 defining a delivery lumen 230 dimensioned to receive the light delivery apparatus 100.
  • the lumen 230 extends between a proximal opening 232 and a distal opening 234.
  • a port 238 of the introducer 210 can be permanently or temporarily coupled to the line 150, as shown in Figure 1.
  • the illustrated port 238 of Figure 3B extends outwardly from the main body 211.
  • An insufflation lumen 237 extends through the port 238 and a portion of the main body 211.
  • the illustrated lumen 237 extends between an inlet 239 and an outlet 241 adjacent the opening 234.
  • introducers can provide access to internal tissue.
  • introducers in the form of delivery sheaths or catheters, cannulas, ports, laparoscopic instruments (e.g., trocar cannulas), sleeves, or other types of access devices can be used.
  • the introducers can be configured to extend through the abdominal wall 122 or other intermediate tissue while allowing for insufflation.
  • the illumination device 110 can be delivered without using any introducers.
  • the illumination device 110 can be inserted directly through a hole (e.g., a hole formed using minimally invasive techniques, open surgical techniques, and the like) in the abdominal wall 122.
  • Figures 4-6 illustrate one embodiment of providing light therapy on the omentum 120.
  • the illumination device 110 is advanced through the abdominal wall 122 via the introducer 210.
  • the space 114 between the omentum 120 and abdominal wall 122 can be insufflated to accommodate the illumination device 110.
  • the light sources 140 are activated to illuminate one or more target regions of the omentum 120.
  • the illumination device 110 can then be removed and reused as desired.
  • the illumination device 110 can be manually inserted into the proximal opening 232 and then advanced distally through the delivery lumen 230. The user manually holds the illumination device 110 in the collapsed configuration. Because the illumination device 110 is collapsed, a relatively small hole 220 and introducer 210 can provide access to the internal cavity 114.
  • the cavity 114 Before, during, and/or after insertion of the illumination device 110, the cavity 114 can be insufflated.
  • the inflated cavity 114 of Figure 5 is filled with fluid F while the illumination device 110 is advanced distally (indicated by the arrow 250) through the delivery lumen 230.
  • the pressurization device 146 shown in Figure 5 delivers fluid F through the line 150 into the introducer 210.
  • the fluid F flows through the introducer 210 into the cavity 114.
  • the pressurization device 146 can accurately adjust the pressure of the fluid F to achieve the desired level of insufflation.
  • Various types of fluids e.g., gases, liquids, or gas/liquid mixtures
  • Exemplary non-limiting fluids include, without limitation, ambient air, water, transmission gels (e.g., light transmission gels) or agents, carbon dioxide, oxygen, combinations thereof, and other bio-compatible materials.
  • the insufflation fluid can also contain one or more additives, such as treatment agents including, without limitation, antibiotics, light sensitive agents, medicaments, and the like.
  • the pressurization device 146 of Figure 5 can be a fluid storage container that contains pressurized fluid.
  • a regulator can control the flow of fluid from the device 146.
  • the pressurization device 146 can comprise at least one pump or other device suitable for pressurizing the fluid F.
  • Other types of pressurization devices or systems can also be used.
  • the device 110 After the illumination device 110 is positioned within the cavity 114, the device 110 self-expands to its enlarged expanded configuration. As shown in Figure 6, the light sources 140 are then activated to illuminate the target tissue 130. These light sources 140 can cooperate to emit a generally uniform field of light rays for a somewhat homogenous treatment of the target tissue such that a substantial portion or most of the emitted light illuminates the target tissue 130. To limit or substantially prevent direct illumination of the abdominal wall 122, the array of light sources 140 can be aimed at the omentum 120 during the entire illumination process, thus minimizing collateral damage to the abdominal wall 122.
  • visualization techniques are used to view the position of the light delivery apparatus 100.
  • Fluoroscopy e.g., x-ray fluoroscopy
  • direct viewing e.g., laparoscopes, endoscopes, and the like
  • CT machines e.g., CT machines, angiography, or other suitable visualization systems
  • a physician can accurately determine the position of the illumination device 110 within the patient in real time.
  • One or more markers can be disposed along the light delivery apparatus 100.
  • the number and position of the markers can be selected based on the treatment to be performed.
  • the markers may be made from a material readily identified after insertion into a patient's body by using visualization techniques, such as the techniques noted above. If x-ray fluoroscopy is employed, the markers are preferably made from gold, tungsten, or any other readily identifiable material.
  • a viewing element is coupled to the light delivery apparatus 100.
  • the viewing element can be an optical fiber, camera, or other device that can capture images.
  • the illuminated tissue is viewable to ensure proper treatment.
  • the light delivery apparatus 100 is integrated with an endoscopic instrument, such as a laparoscope.
  • a viewing element can be provided on a separate delivery tool.
  • the light delivery apparatus 100 can be passed through a working lumen of an endoscope, which has a viewing element.
  • Figures 7 to 27 show embodiments of light delivery apparatuses that are generally similar to the light delivery apparatus 100 illustrated in Figures 1 to 6, except as further detailed below.
  • Figures 7 to 10 show a light delivery apparatus
  • the illumination device 302 includes a flexible sheet 340 and an array of light sources 342 coupled to the sheet 340.
  • the sheet 340 is made, in whole or in part, of an opaque material that inhibits or substantially prevents light emitted from the light sources 342 from passing therethrough.
  • the light sources 342 are mounted to a distal face 352 of the sheet 340, and when activated, they emit light outwardly from the distal face 352.
  • the opaque sheet 340 blocks the emitted light and therefore protects the tissue proximal to the sheet ⁇ e.g., the abdominal wall 122). Accordingly, the array of light sources 342 can be conveniently aimed at target tissue while limiting or minimizing collateral tissue damage.
  • the sheet 340 can be formed of a polymer, metal, composite material, shape memory material, or combinations thereof, as well as other materials that are somewhat opaque. In other embodiments, the sheet 340 for emitting light in opposite directions may comprise one or more optically transparent materials.
  • the device 302 with a transparent sheet 340 may emit light in opposite directions (e.g., distally and proximally) to treat target tissue on opposing sides of a body cavity.
  • the main body 312 includes a central body 350 and a mounting tip 354 rotatably mounted to a distal end 360 of the central body 350.
  • the mounting tip 354 is movable between a low profile position ( Figure 11A) and a deployment position ( Figure 11 B).
  • the illumination device 302 is unrestrained, the mounting tip 354 can rotate from the low profile position to the deployment position, as indicated by the arrow 366 of Figure 11 A.
  • the unrestrained mounting tip 354 rotates outwardly until it reaches its deployment position to allow the sheet 340 to expand into its deployed configuration, as shown in Figure 9.
  • the sheet 340 can easily expand by an unfurling process, without interference from the central body 350.
  • the mounting tip 354 shown in Figure 11 B is generally perpendicular to the central body 350; however, other positions of the mounting tip 354 are also possible.
  • the main body 312 can comprise a shape memory material for self- deploying.
  • the main body 312 can comprise wire formed of shape memory material, such as NiTi, that is thermally activatable to move the mounting tip 354.
  • the controller 326 operates a heating element that heats the main body 312 to the desired temperature for thermal activation of the shape memory material.
  • the light sources 342, when activated, generate a sufficient amount of heat to cause thermal activation of the shape memory material.
  • the light sources 342 may be evenly or unevenly spaced along the sheet 340.
  • the illustrated light sources 342 are somewhat evenly spaced from each other.
  • the illustrated light delivery apparatus 300 of Figure 7 includes a power source 370 electrically coupled to the light sources 342 by a lead 372 extending along next to a portion of the main body 312.
  • the lead 372 can extend through a lumen in the main body 312 to further reduce the profile of the apparatus 300.
  • One of ordinary skill in the art can select the position and configuration of the lead 372 based on the procedure to be performed.
  • the illumination device 302 in the low profile configuration is delivered into a patient via an introducer. After the illumination device 302 is within the patient, the illumination device 302 can be rotated outwardly to the deployment position to allow the sheet 340 to then unfurl within the body cavity. For convenient and rapid expansion, the sheet 340 can be self- expanding. After the light sources 342 illuminate target tissue, the sheet 340 can be rolled-up and returned to its pre-deployment configuration. The mounting tip 354 is then rotated from the deployment position to the low profile position for convenient removal.
  • the illustrated sheet 340 of Figure 9 has a generally polygonal shape (illustrated as a quadrilateral parallelogram), as viewed from above. However, the sheet 340 can have other configurations.
  • Figure 12A illustrates a generally circular sheet 400.
  • Figure 12B illustrates a generally triangular sheet 402.
  • Figure 12C illustrates a generally hexagonal sheet 406.
  • Figure 12D illustrates a sheet 407 having a combination of linear and arcuate sides. These sheets can also have uniform or varying thicknesses so long as they can be suitably positioned within the patient.
  • Figures 13 and 14 show an illumination device 420 that is generally similar to the illumination device 302 of Figures 7-11 B, except as detailed below.
  • the illustrated illumination device 420 has a folded, collapsed configuration (Figure 13) and an unfolded, expanded configuration ( Figure 14), and includes an illumination device body 430 and an array of light sources 440 coupled to the illumination device body 430.
  • the illumination device body 430 includes a plurality of elongate panels hingedly coupled together to form a foldable sheet. When the illumination device 420 is in the expanded configuration, adjacent panels can be angled to each other, as shown in Figure 14, or the expanded illumination device 420 can be generally flat.
  • the illumination device 420 can be folded and unfolded any number of times to perform any desired number of treatments.
  • Figures 15-17 show an illumination device 500 having an actuatable sheet holder 510 mounted to a main body 518.
  • the actuatable sheet holder 510 can be actuated to move a pair of sheets 522, 524 between a collapsed configuration ( Figure 15) and an expanded configuration ( Figure 17).
  • a plurality of outwardly deployable legs 530a, 530b, 530c, 53Od of the holder 510 are rotatably mounted to a hub 540, which is fixedly coupled to the main body 518.
  • the distal ends of the legs 530b, 530c are coupled to opposing sides of the sheet 522.
  • the distal ends of the legs 530a, 53Od are coupled to opposing sides of the sheet 524.
  • the distal ends of the legs 530a-d are moved outwardly to unfold the sheets 522, 524 such that the generally flat expanded sheets 522, 524 are positioned next to each other and generally perpendicular to a longitudinal axis 525 of the main body 518, as shown in Figure 17.
  • Figures 18-20 illustrate a manually deployable light delivery apparatus 600 that includes a deployment control assembly 610, an illumination device 616, and a main body 620 extending therebetween.
  • the control assembly 610 includes a plunger 640 and a pair of control elements 644a, b.
  • the plunger 640 is depressed linearly to rotate the illumination device 616 from a low profile delivery position ( Figure 18) to a deployment position ( Figure 19).
  • the control elements 644a, b are then used to move the illumination device 616 into an expanded configuration ( Figure 20).
  • an actuating system 660 is formed by a distal end 670 of the plunger 640 and a coupling member 680 fixedly coupled to flexible elongated members 690a, b.
  • a pin 692 can pivotally couple the distal end 670 to the coupling member 680 such that, when the plunger 640 is depressed, the distal end 670 pushes the member 680 thereby causing rotation of the flexible elongated members 690a, b (indicated by the arrow 691 of Figure 21).
  • the plunger 640 can also be pulled proximally to return the illumination device 616 to the low profile position. In this manner, the illumination device 616 can be repeatedly actuated between the low profile and deployment positions.
  • control elements 644a, b are fixedly coupled to the elongate members 690a, b, respectively, and rotatably disposed within the main body 620.
  • the control elements 644a, b can be rotated towards each other (indicated by the arrows 700, 702 of Figure 19) to correspondingly rotate the elongate members 690a, b outwardly (indicated by the arrows 703, 705 of Figure 20) causing the furled illumination device 616 to unfurl from the elongate members 690a, b.
  • the light sources 693 coupled to the sheet 641 can then be activated to perform light therapy.
  • the unfurled illumination device 616 can be furled once again about the elongated members 690a, b.
  • the furled illumination device 616 can be returned to the low profile position for subsequent removal from the subject.
  • Figures 23-26 illustrate a manually deployable light delivery apparatus 730.
  • the light delivery apparatus 730 includes an actuating system 740 having a plunger 742 slidably retained in a main body 744.
  • a deployable illumination device 750 is coupled to the main body 744.
  • the plunger 742 can be pulled proximally to cause central portions of straight, flexible struts 760 to bulge outwardly away from a longitudinal axis 763 of the illumination device 750.
  • the proximal ends of the struts 760 are coupled to the main body 744, and the distal ends of the struts 760 are coupled to a distal end 794 of the plunger 742.
  • One or more light sources 780 can be coupled to each of the struts 760. When the illumination device 750 is in the deployed configuration, the light sources 780 can be directed distally such that, when activated, light rays are emitted distally, thereby protecting tissue positioned proximal to the illumination device 750.
  • the plunger 742 includes an engagement portion 790 and a plunger body 792.
  • a handle 798 on the main body 744 is provided for convenient leveraging of the plunger 742.
  • the collapsed illumination device 750 can be inserted through an opening 800 in an abdominal wall 810, as shown in Figure 26.
  • the actuating system 740 is operated to expand the illumination device 750.
  • the light sources 780 are activated to illuminate the target site 820 positioned in front of the illumination device 750, thereby protecting the abdominal wall 810 from the emitted light.
  • one or more light sources can be coupled to the proximal portions of the struts 760 facing the abdominal wall 810.
  • Figure 27 shows a treatment system 900 that includes a selectively deployable inflatable member 902 that surrounds an illumination device 906 of a light delivery apparatus 910.
  • the device 906 can be similar to the illumination devices described above in connection with Figures 1 to 26.
  • the illustrated inflatable member 902 can be inflated from a low profile, deflated configuration to an inflated configuration (as shown) and can transmit light emitted from the illumination device 906 to the omentum 120.
  • the inflatable member 902 includes a main inflation body 920 for surrounding the device 906 and a proximal portion 922 for engaging the subject.
  • the main inflation body 920 can be made of any thin, flexible material, such as silicone, polyurethane, latex (e.g., natural or synthetic latex), or other materials that are used for pressure balloons, for example.
  • the material type and wall thickness of the member 902 can be selected based on the desired inflation pressure, inflation size, and optical properties.
  • the flexible inflatable member 902 comprises a somewhat transparent compliant material, preferably an optically transparent polyester. At least one wavelength of light emitted by the illumination device 906 can pass through the inflatable member 902.
  • Suitable transmissive materials for forming the inflatable member 902 include, but are not limited to, polymers such as polyester, PET, polypropylene, combinations thereof, and the like. In some embodiments, at least 40% of the light emitted towards the inflatable member 902 is transmitted therethrough. In some embodiments, at least 50% of the light emitted towards the inflatable member 902 is transmitted therethrough. In other embodiments, at least 60% of the light emitted towards the inflatable member 902 is transmitted therethrough. In yet other embodiments, at least 70% of the light directed towards the inflatable member 902 is transmitted therethrough. In some other embodiments, at least 80% of the light directed towards the inflatable member 902 is transmitted therethrough. In still other embodiments, at least 90% of the light directed towards the inflatable member 902 is transmitted therethrough. Additionally, one or more light passageways, through-holes, windows, or other structures can be formed in the inflatable member 902 to increase the amount of light passing through the inflatable member 902.
  • the inflatable member 902 can optionally include one or more opaque materials that can inhibit or prevent one or more wavelengths or wavebands from passing therethrough.
  • Opacification agents, additives, coatings, or combinations thereof can be utilized to render the inflatable member 902 (or portion thereof) somewhat opaque.
  • Opacification agents can include, but are not limited to, dyes, pigments, metal particulates or powder, or other materials that can be coated onto, disbursed throughout, or otherwise disposed in a wall 927 of the inflatable member 902.
  • the inflatable member 902 can function as a filter so as to inhibit or prevent one or more wavelengths or wavebands from reaching the patient's tissue.
  • an inflation fluid e.g., a gas, liquid, or gas/liquid mixture
  • an inflation fluid can fill a chamber 930 until the inflatable member 902 reaches a desired inflated configuration.
  • the inflatable member 902 can be controllable inflated using the techniques, fluids, and devices described above.
  • a pressurization device can accurately adjust the pressure of an inflation fluid to achieve the desired level of inflation.
  • Exemplary non-limiting fluids include, without limitation, ambient air, saline, water, transmission gels ⁇ e.g., light transmission gels) or agents, carbon dioxide, oxygen, insufflation fluid, combinations thereof, and other bio-compatible materials.
  • the illustrated treatment system 900 is used to enlarged the cavity 114 without using an insufflating system. That is, the inflatable member 902 itself causes enlargement or expansion of the cavity 114 by physically contacting and pushing against the patient's tissue.
  • an insufflating system (such as the insufflating system 141 of Figure 1) can be used to insufflate the cavity 114 before, during, or after placement of the inflatable member 902.
  • the cavity 114 is not enlarged or expanded during treatment.
  • the system 900 can be used in natural anatomical cavities that accommodate the system 900 without disturbing the patient's tissue.
  • a catheter 944 shown in Figure 27 can have an inflation lumen for delivering fluid into the inflatable member 902 via an outlet port 940.
  • the deflated inflation member 902 can be easily inserted through the abdominal wall 122 into the cavity 114. Once positioned in the cavity 114, the inflatable member 902 can be enlarged from the deflated configuration to a partially or fully inflated configuration by fluid flowing out of the outlet port 940. Because the inflatable member 902 defines a large internal chamber 943, the illumination device 906 can be freely expanded without striking the patient.
  • the illumination device 906 can emit light to treat the target tissue.
  • the light travels through the inflation fluid, through the wall 927 of the inflatable member 902, and to the omentum 120.
  • the inflatable member 902 can rest against the target tissue.
  • the inflatable member 902 may be sufficiently compliant to conform to the shape to the omentum 120 without injuring or significantly traumatizing the tissue while ensuring efficient light transmission to the target tissue of interest.
  • the inflatable member 902 can be distanced from the target tissue, or any other tissue during the light delivery process, to prevent trauma to internal tissue.
  • the exterior of the inflatable member 902 can have any desired shape or contour based on the procedure to be performed.
  • the inflation member 902 can be fixedly coupled to the catheter 944 such that the illumination device 906 is permanently fixed relative to the inflation member 902.
  • the inflation member 902 can be movable with respect to the catheter 944.
  • the inflation member 902 can be slidably coupled to the catheter 944 to permit movement of the illumination device 906 through the inflation member 902 for improved maneuverability.
  • Various types of mounting arrangements can be used to movably couple the proximal end 922 of the member 902 to the catheter 944.
  • the proximal end 922 of the inflation member 902 can engage the abdominal wall 122.
  • a seal (e.g., a hermetic seal) may be formed between the proximal end 922 and wall 122 to limit, minimize, or substantially prevent any fluid from escaped out of the cavity 114, especially if pressurized fluid is in the cavity 114.
  • Sealing members, compliant rings, or other sealing components can provide the desired interaction between the proximal end 922 and wall 122.
  • the inflatable member 902 can define an outer atraumatic surface that minimizes, limits, or substantially eliminates trauma to the patient.
  • the wall of the inflatable member 902 serves as a protective barrier between the illumination device 906 and the patient to reduce the likelihood of trauma to the patient allowing the illumination device 906 to be freely maneuvered within the cavity 114 without an appreciable risk of injuring the patient.
  • the inflatable member 902 can be deflated for subsequent removal from the patient.
  • the illumination device 906 and inflatable member 902 can be collapsed sequentially or simultaneously.
  • the inflatable member 902 can be used to perform another procedure or discarded.

Abstract

A light delivery apparatus to provide light treatment to a patient includes a deployable illumination device having a plurality of light sources that transmit light towards a target site within a patient. In one embodiment, the deployable illumination device can be moved between a collapsed configuration for insertion into the patient and an expanded configuration for performing light therapy. An introducer can be used to provide access to an insufflated cavity sized to accommodate the illumination device before, after, and/or during the expansion process.

Description

LIGHT DELIVERY APPARATUS AND METHODS FOR ILLUMINATING
INTERNAL TISSUES
CROSS-REFERENCE TO RELATED APPLICATION
This application claims the benefit under 35 U. S. C. § 119(e) of U.S. Provisional Patent Application No. 60/851 ,098 filed October 11 , 2006. This provisional application is incorporated herein by reference in its entirety.
BACKGROUND
Field
The present invention relates generally to a light delivery apparatus usable for medical treatment, such as light therapy for the treatment of internal tissues.
Description of the Related Art
Obesity is often caused by an excessively high caloric intake which leads to accumulation of surplus fat and various types of diseases (e.g., diabetes). Obesity can lead to various problems ranging from a loss of mobility to causing a shortened lifespan. Various weight loss techniques, such as dieting, are often used by people suffering from obesity. Even people of healthy weight may wish to control their weight for health and cosmetic reasons.
Dieting often requires that significant limitations be placed on caloric, fat, and carbohydrate intake. Unfortunately, due to the inherent causes of obesity and overeating, dieting by itself is often unsuccessful in achieving the patient's goals. A patient may have to exercise an immense amount of patience and discipline in order to lose significant amounts of weight. There may also be inherent reasons that people eat excessively. For example, a person may overeat to satisfy anxiety. Thus, satisfying secondary needs in the individual's life (i.e., not to satisfy hunger) may also lead to obesity.
Appetite suppression can be used for weight control. Drugs (e.g., centrally-acting neuro-stimulants like cocaine, methamphetamine hydrochloride, dextroamphetamine sulfate, and other derivatives of the amphetamine molecule) can be used for appetite suppression. These drugs typically are only effective for a short period of time and may have inherent unwanted side effects. Invasive medical procedures, such as liposuction, are often used to remove fat but require significant periods of recovery time. Invasive procedures further subject the patient to risks of infection and bleeding, anesthesia risks, and other post-surgical complications. By way of example, liposuction involves the introduction of probes around 5 mm in diameter through holes in the skin to remove adipose tissue. Unfortunately, liposuction often causes permanent depressions in the zone of insertion of the probe, excessive bleeding, and nonselective removal of fat cells and the cells of the stroma. The permanent depressions can result in an unnatural skin appearance.
Traditional surgical procedures may be unsuitable for removing intra- abdominal fat. Intra-abdominal fat, such as omentum fat, can surround and protect the human bowels. Unfortunately, perforating the abdomen with a liposuction cannula, for example, to reach the omentum fat can cause an infection, such as peritonitis. Additionally, physically removing omentum fat can damage the omentum thereby increasing the overall recovery period.
BRIEF SUMMARY OF THE INVENTION
The embodiments described herein are generally related to a treatment system usable for treating one or more internal target sites of a subject. By using minimally invasive techniques, a light delivery system can treat target sites at different depths and positions in an individual's body. The target sites can include, without limitation, diseased tissues (e.g., cancerous cells), interstitial tissues, epithelial tissues, connective tissues (e.g., blood, cartilage, and/or bone), nerve tissues, or other regions of interest. The target site can be treated with or without using medicaments (e.g., treatment agents or photosensitive agents). For example, the disclosed embodiments can treat at least a portion of the omentum to destroy omentum fat, with or without utilizing photosensitive agents (e.g., photo- reactive agents), or other energy activated agents.
A light delivery apparatus of the treatment system can perform different types of light therapies. As used herein, the term "light therapy" and its variants are to be construed broadly to include, without limitation, methods of treating a patient with light applied externally and/or internally. Light therapy can be used to treat various types of medical conditions (e.g., proliferative diseases including cancer) and cosmetic conditions. In some embodiments, these procedures are performed without physically contacting the target tissues, thereby minimizing trauma to the subject and reducing recovery periods. Because minimally invasive techniques can be used, the light delivery apparatus can reduce the risk of infection or internal bleeding. Unlike surgical tissue removal producers (e.g., liposuction), tissue treated by light therapy can be destroyed and reabsorbed naturally by the body. Thus, light therapy can be performed relatively quickly without using tissue removal instruments. The light delivery apparatuses can selectively treat specific target tissues, even remote subcutaneous tissues. A localized region of target tissue can be treated without treating or otherwise significantly affecting non-targeted tissues, thereby providing improved treatment flexibility in administering a particular treatment. The light delivery apparatuses can be used for diagnostic, therapeutic, cosmetic, and/or other types of procedures.
In some diagnostic applications, the light delivery apparatus can emit light with a wavelength selected to cause the photo-reactive agent to fluoresce as a means to acquire information about the targeted cells without damaging the targeted cells. In some therapeutic and cosmetic applications, the wavelength of light delivered to the targeted cells treated with the photo-reactive agent causes the agent to undergo a photochemical reaction with oxygen in the localized targeted cells, to yield free radical species (such as singlet oxygen), which causes localized cell destruction (e.g., cell lysis), size reduction, or necrosis, for example. Light can be delivered to the target tissue without physically contacting the target tissue.
In some cosmetic applications, the light delivery apparatus can treat deposits of fat, which can cause a particular area of the patient's body to appear disproportionate. These localized fat deposits may not be sufficiently reduced in size through dieting, exercise, and other traditional weight loss techniques. The light delivery apparatus, however, can treat these fat deposits resulting in a more proportionate body. In some embodiments, the fat tissue is destroyed or reduced in size, and if the skin has enough elasticity, the skin can achieve a naturally appearing smooth contour. If the skin in proximity to the treatment site is unsuitably inelastic, one or more skin tightening procedures may be performed to achieve the desired overall appearance. Various access techniques can be used to deliver the light delivery apparatus. Open procedures, semi-open procedures, laparoscopic procedures, and minimally invasive procedures can provide suitable access to the target site. Known conventional surgical instruments (e.g., sizing rings, balloons, calipers, gauges, delivery sheaths, cannulas, and the like) for accessing internal tissue can be used. Many times, the access techniques and procedures can be performed by the surgeon and/or a robotic device, such as robotic systems used for performing minimally invasive heart surgery. Those skilled in the art recognize that there are many different ways to access internal tissue.
In some embodiments, the light delivery apparatus has an illumination device that is folded, furled, rolled-up, or otherwise in a low profile arrangement when in a collapsed configuration. The illumination device can be unfolded, unfurled, unrolled, expanded outwardly, or otherwise enlarged to assume an expanded configuration for emitting light rays suitable for treating target tissue. In some embodiments, the light delivery apparatus is rotationally locked thereby ensuring proper positioning during the illumination procedure. The illumination device can thus be easily positioned and aimed at the target tissue.
The treatment agent for use with the light delivery apparatus can be administered locally, systemically, orally, or by injection, which may be intravenous, subcutaneous, intramuscular, or intraperitoneal. The treatment agent also can be administered externally or topically via patches or implants.
Visceral fat, such as panniculus adipose tissue, may have a contributory role in medical conditions, such as type Il diabetes. The reduction of this visceral fat may improve a patient's condition. If a person is suffering from type Il diabetes, for example, the reduction of visceral fat may reverse or improve insulin resistance, diabetes syndrome, and/or metabolic syndrome. This can lead to reduced medical costs associated with diabetes. The frequency and likelihood of complications (e.g., heart disease, renal failure, foot ulcers, and diabetic retinopathy, and the like) of diabetes can also be reduced or eliminated. The light delivery apparatus can destroy fat cells to reduce the amount of visceral fat.
The treated adipose cells may break down (e.g., immediately or gradually over an extended period of time) and are subsequently absorbed by the patient's body. In this manner, the amount of visceral fat can be reduced in a controller manner. This procedure can be performed any number of times at different locations until the desired amount of fat has been eliminated. For example, visceral fat can be removed until achieving a noticeable improvement in insulin resistance. Of course, fat at other target sites can also be treated in a similar manner. Thus, fat deposits can be precisely destroyed or eliminated for health or cosmetic reasons. Moreover, because the system may have a low profile, the system can be delivered to remote locations using minimally invasive techniques. In some embodiments, a method of treating visceral adipose tissue includes providing a catheter having a distal end with a plurality of light sources movable with respect to one another. The distal end is sufficiently flexible for placement within a patient. The distal end of the catheter is advanced through the patient until the distal end is proximate to the visceral adipose tissue. The visceral adipose tissue is illuminated with the plurality of light sources. Illuminating the visceral adipose tissue with the plurality of light sources includes activating a treatment agent in the visceral adipose tissue so as to destroy at least a portion of the adipose tissue. The treatment can be repeated to destroy a desired amount of tissue. The systems disclosed herein can be used to perform this method. In some embodiments, a light delivery apparatus for treating a subject comprises a deployable illumination device. The deployable illumination device has at least one light source capable of emitting light that activates a therapeutically effective amount of a treatment agent in target tissue. In some variations, the light delivery apparatus also has a main body coupled to the illumination device. The main body is configured to carry the illumination device to a location near the target tissue. The main body can be rod, catheter body, or other rigid or flexible structure.
In some embodiments, a light delivery apparatus for treating a subject comprises a light emitting tip. The light emitting tip is movable between a low profile configuration and an expanded illumination configuration. The therapy tip also has at least one light source or optical fiber, which is positioned to deliver light to a target site in the subject when the tip is in the illumination configuration.
In some embodiments, a method of treating target tissue of a subject is provided. The method comprises advancing an illumination device into the subject. The illumination device has at least one light source adapted to emit light capable of activating a treatment agent. A space between a first layer of tissue and a second layer of tissue in the patient is insufflated. The illumination device is positioned in the space, and the first layer of tissue is illuminated with light from the at least one light source.
In some embodiments, a light system is provided to perform a method of treating target tissue of a subject. The method comprises advancing an illumination device into the subject. The illumination device has at least one light source adapted to emit light capable of activating a treatment agent. A space between a first layer of tissue and a second layer of tissue in the patient is insufflated. The illumination device is positioned in the space, and the first layer of tissue is illuminated with light from the at least one light source.
In some embodiments, a light treatment system for treating target tissue of a subject is provided. An illumination device of the light treatment system has at least one light source that emits light capable of activating a treatment agent. The light treatment system insufflates a space between a first layer of tissue and a second layer of tissue in the subject. The illumination device is positioned in the space, and the first layer of tissue is illuminated with light from the at least one light source.
In some embodiments, a light delivery apparatus includes an illumination device dimensioned for placement in a body of the subject. The illumination device has a first preset configuration and a second preset configuration. A plurality of light sources is coupled to the illumination device and become exposed when the device moves from the first configuration to the second configuration.
In yet other embodiments, a light delivery apparatus for treating a subject includes an illumination device dimensioned for placement in a cavity in a body of the subject. The illumination device has a first preset configuration and a second preset configuration. A plurality of light sources is coupled to the illumination device. An outermost pair of the light sources defines a first transverse width when the illumination device is in the first configuration and an outermost pair of the light sources defines a second transverse width greater than the first transverse width when the illumination device is in the second configuration. In some variations, the illumination device has a long axis, and the light sources are moved away from the long axis as the illumination device moves from the first preset configuration towards the second preset configuration.
In some embodiments, a light delivery apparatus can be used to treat a target site of tissue to promote tissue growth (e.g., cell division, cell growth or enlargement, etc.), increase the rate of healing, improve circulation, reduce or minimize pain, relieve stiffness, and the like. The light delivery apparatus can illuminate different types of tissue, such as muscle, bone, cartilage, or other suitable tissue, without using a treatment agent. One or more light sources of the light delivery apparatus can be adapted to emit light with near-infrared or infrared wavelengths. This light itself can cause tissue growth. Alternatively, the light delivery apparatus can be used in combination with growth enhancers, growth factors, and the like.
The light delivery apparatus can also be used to destroy tissue by emitting energy that causes cell destruction. One or more energy sources of the light delivery apparatus can be activated to generate enough heat for cell destruction. If the energy sources are LEDs, the LEDs, when activated, can generate a sufficient amount of heat to cause tissue damage. In other embodiments, the energy sources can emit ultraviolet light that destroys the target cells. Such embodiments are especially well suited for destroying a thin layer of tissue without using a treatment agent or damaging an underlying layer of tissue.
In some embodiments, a light delivery system for performing light therapy on a subject is provided. The light delivery system includes an introducer adapted for placement in an opening in tissue of the subject and a deployable illumination device. The deployable illumination device has a plurality of light sources or optical fibers capable of emitting light. The illumination device is movable from a collapsed configuration to an expanded configuration to move the plurality of light sources into a deployed configuration. In some embodiments, the illumination device, in the collapsed configuration, has a first transverse width and the illumination device, in the expanded configuration, has a second transverse width substantially greater than the first transverse width. For example, the second transverse width can be equal to or greater than 2 times the first transverse width. In other embodiments, the second transverse width can be equal to or greater than 3 times the first transverse width.
In some embodiments, the system further comprises an elongate main body coupled to the illumination device. The elongate main body is configured to carry the illumination device along a lumen of the introducer into a space adjacent target tissue of the subject. After passing through the lumen closely surrounding the illumination device, the illumination is expanded outwardly.
In some embodiments, the illumination device has a long axis. The light sources are moved away from the long axis as the illumination device moves from the first configuration towards the second configuration.
In some embodiments, the light delivery system includes an insufflating system. The insufflating system may include a pressurization device and a fluid line coupled to the pressurization device to provide fluid communication between the cavity and the pressurization device. The pressurization device is adapted to insufflate the cavity when activated. BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
In the drawings, identical reference numbers identify similar elements or acts. The sizes and relative positions of elements in the drawings are not necessarily drawn to scale. For example, the shapes of various elements and angles may not be drawn to scale, and some of these elements may be arbitrarily enlarged and positioned to improve drawing legibility.
Figure 1 is a side elevational view of a light delivery apparatus extending through an introducer, where an illumination device of the light delivery apparatus is positioned within a body cavity of a subject.
Figure 2A is a side elevational view of a light delivery apparatus with an illumination device in a collapsed configuration, in accordance with one illustrated embodiment.
Figure 2B is a side elevational view of the light delivery apparatus of Figure 2A where the illumination device is in an expanded configuration.
Figure 3A is a side elevational view of an introducer, in accordance with one illustrated embodiment.
Figure 3B is a longitudinal cross-sectional view of the introducer of Figure 3A. Figure 4 is a side elevational view of a light delivery apparatus positioned outside of a patient, in accordance with one illustrated embodiment.
Figure 5 is a side elevational view of the illumination device of the light delivery apparatus positioned within an introducer.
Figure 6 is a side elevational view of the illumination device positioned in a body cavity.
Figure 7 is a perspective view of a light delivery apparatus, in accordance with another embodiment.
Figure 8 is a perspective view of an illumination device of the light delivery apparatus of Figure 7, where the illumination device is in a deployment position. Figure 9 is a perspective view of the illumination device of the light delivery apparatus of Figure 7, where the illumination device is in an expanded configuration.
Figure 10 is a front elevational view of the expanded illumination device of the light delivery apparatus of Figure 7.
Figures 11A and 11 B are side elevational views of a main body of the light delivery apparatus of Figure 7 has a movable mounting tip, in accordance with one illustrated embodiment.
Figures 12A to 12D are top elevational views of sheet assemblies. Figure 13 is a perspective view of an illumination device in a collapsed configuration, in accordance with one illustrated embodiment.
Figure 14 is a perspective view ofthe illumination device of Figure 13 in an expanded configuration.
Figure 15 is a perspective view of an illumination device in a collapsed configuration, in accordance with one illustrated embodiment.
Figure 16 is a perspective view ofthe illumination device of Figure 15 in a partially expanded configuration.
Figure 17 is a perspective view of the illumination device of Figure 15 in a fully expanded configuration. Figure 18 is a perspective view of a light delivery apparatus with a collapsed illumination device in a low profile position, in accordance with one illustrated embodiment.
Figure 19 is a perspective view ofthe illumination device of Figure 18 in a deployment position. Figure 20 is a perspective view ofthe illumination device of Figure 18 in an expanded configuration.
Figure 21 is a side elevational view of an actuating assembly of the light delivery apparatus of Figure 18, where the illumination device is in a low profile position. Figure 22 is a side elevational view of the actuating assembly of
Figure 21 , where the illumination device is in a deployment position. Figure 23 is a side elevational view of a light delivery apparatus having an illumination device in a collapsed configuration.
Figure 24 is a side elevational view of the light delivery apparatus of Figure 23, where the illumination device is in an expanded configuration. Figure 25 is a bottom elevational view of the light delivery apparatus of Figure 23.
Figure 26 is a side elevational view of the illumination device of the light delivery apparatus positioned within a body cavity.
Figure 27 is a side elevational view of a light delivery apparatus, where an inflatable member is positioned within a body cavity and surrounds a deployed illumination device.
DETAILED DESCRIPTION OF THE INVENTION
Figure 1 shows a treatment system 90 including a light delivery apparatus 100 for performing light therapy. The light delivery apparatus 100 includes a deployable illumination device 110 and an elongate main body 112 coupled to the illumination device 110. The illumination device 110 is positioned within an internal space or cavity 114 between an omentum 120 and an abdominal wall 122. When activated, the illumination device 110 emits light rays towards the omentum 120. This light can interact with one or more treatment agents to photo- activate or photo-excite target tissue 130 {e.g., intra-abdominal fat) in or around the omentum 120. The light can therefore cause localized cell destruction, size reduction, and/or necrosis of intra-abdominal fat resulting in weight loss.
Intra-abdominal fat, including mesenteric adipose tissue and omental adipose tissue, can be located in the peritoneal cavity. This tissue may contribute to the onset of diseases, including metabolic disorders (e.g., arteriosclerosis, diabetes, and/or hyperlipemia) and cardiac vessel disorders. The emitted light can destroy, reduce in size, or otherwise treat the adipose tissue such that these diseases can be reversed or otherwise improved. Advantageously, the light delivery apparatus 100 can treat adipose tissue without physically contacting the adipose tissue or tissue proximate the adipose tissue, thus minimizing trauma to the patient. As shown in Figure 1 , for example, the illumination device 110 can be activated while being spaced from both the omentum 120 and abdominal wall 122. Additionally, the illumination device 110 is relatively small for convenient navigation within the cavity 114 but capable of illuminating a relatively large area of target tissue.
With continued reference to Figure 1 , the illumination device 110 has an array of light sources 140 for emitting light. The light sources 140 can uniformly illuminate the target tissue 130 to ensure somewhat homogenous activation of the treatment agent therein. The target tissue 130 may be subjected to at least one wavelength of light that is approximately close to, if not the equivalent to, at least one excitation wavelength of the treatment agent, according to some embodiments. It is understood that even if one cell is targeted, it is possible that other cells in the vicinity of the targeted cell may also be subjected to light emitted from the one or more light sources. It is contemplated that the illumination device 110 can be expanded or contracted during, before, and/or after the light sources 140 are activated. Thus, the light field can be adjusted by altering the configuration of the illumination device 110.
An insufflating system 141 can form and size the internal cavity 114 via an expansion process. The cavity 114 is dimensioned to accommodate the illumination device 110 before, during, and/or after the expansion process. Because the illumination device 110 has a low profile in its collapsed configuration (as discussed in connection with Figures 2A and 2B), the illumination device 110 can be passed into the cavity via a narrow hole in the abdominal wall 122 and then expanded within the cavity 114.
The insufflating system 141 includes a pressurization device 146 in fluid communication with the cavity 114 via a fluid line 150. To insufflate the natural cavity between the omentum 120 and abdominal wall 122, the pressurization device 146 delivers a liquid/gas through the line 150 to an introducer 210, which in turn delivers the liquid/gas into the cavity 114. The liquid/gas fills and expands the cavity 114. The volume of the cavity 114 can increase at least 50%, 100%, 200%, 500%, or ranges encompassing such percentages, by using the insufflating system 141.
Figures 2A and 2B show the light delivery apparatus 100 including the illumination device 110, a control assembly 170, and the main body 112 extending therebetween. The illumination device 110 is movable between a collapsed configuration (Figure 2A) and an expanded configuration (Figure 2B). The collapsed illumination device 110 has a relatively low profile for delivery through small openings. When the illumination device 110 is in the expanded configuration, the array of light sources 140 can be aimed distally, as shown in Figure 1. Accordingly, the sources 140 can illuminate a target region of the omentum 120 without illuminating collateral tissue. In this manner, the illumination device 110 protects the abdominal wall 122 from inadvertent light therapy. Of course, some emitted light, in some instances, may be reflected through the cavity 114 to collateral tissue; however, the amount of activated treatment agent in non- targeted tissue can be kept at or below an acceptable level.
When the illumination device 110 is collapsed, an outermost pair of light sources defines a first transverse width T1 (Figure 2A). When the illumination device 110 is in the expanded configuration, an outermost pair of light sources defines a second transverse width T2 (Figure 6). The second transverse width T2 is greater than the first transverse width T1. The outermost pairs of light sources, when the illumination device is in the collapsed configuration and expanded configuration, can be the same pair of lights or a different pair of lights.
The illustrated illumination device 110 of Figure 2B includes a hub
182 and a plurality of elongate struts 180a, 180b, 180c rotatably coupled to the hub 182. The elongate struts 180a, 180b, 180c have distal ends 181a, 181b,
181c, respectively, that can be moved outwardly in the radial direction until reaching a fully expanded configuration. The proximal ends 183a, 183b, 183c of the respective elongate struts 180a, 180b, 180c are coupled to the hub 182.
Hinges, pivots, flexible connectors, or other suitable structures can rotatably couple the proximal ends 183a, 183b, 183c to the hub 182.
Each of the elongate struts 180a, 180b, 180c can carry at least one light source 140. The light sources 140 can be LEDs (such as edge emitting LEDs, surface emitting LEDs, super luminescent LEDs), laser diodes, and the like. The illustrated light sources can emit appropriate wavelength(s) or waveband(s) suitable for treating the patient, with or without using a treatment agent, as noted above. If a treatment agent {e.g., a photo-reactive or photosensitive agent) is utilized, the light sources may emit radiation wavelength(s) or waveband(s) that correspond with, or at least overlap with, the wavelength(s) or waveband(s) that excite or otherwise activate the agent. Photosensitive agents can often have one or more absorption wavelengths or wavebands that excite them to produce substances which damage, destroy, or otherwise treat target tissues of the patient. The photosensitive agents and light sources can be selected to achieve the desired interaction.
For example, the light sources 140 can be configured to emit light having one or more wavelengths in the red spectrum and/or infrared spectrum. The sources 140 can emit light, for example, having a wavelength or waveband in the range from about 400 nanometers to about 1 ,000 nanometers. In some embodiments, the light sources 140 emit a wavelength or waveband in the range from about 600 nanometers to about 800 nanometers. In some embodiments, the light sources emit a wavelength or waveband in the range from about 600 nanometers to about 700 nanometers. In one embodiment, for example, the light sources emit radiation with a peak wavelength of 664 nanometers plus or minus 5 nanometers.
The light sources 140 can emit the same or similar wavelength or waveband. However, light sources 140 having different wavelengths or wavebands can be used to provide varying outputs. These light sources 140 can be activated simultaneously or at different times depending on the desired treatment.
In some embodiments, including the illustrated embodiment of Figure 2B, each of the elongate struts 180a, 180b, 180c carries three light sources 140. Any number of light sources can be coupled to each of the struts 180a, 180b, 180c. The number, types, and positions of the light sources 140 can be selected to produce evenly or unevenly distributed light rays.
The illumination device 110 of Figures 2A and 2B can be self- expanding for convenient deployment. In some self-expanding embodiments, the struts 180a, 18Ob1 180c are biased radially outward. During delivery, the struts 180a, 180b, 180c are radially restrained to inhibit or limit self-expansion. Once released, the struts 180a, 180b, 180c rotate outwardly to their expanded configurations. For example, the illumination device 110 can be passed through a lumen of a delivery catheter. The lumen walls can restrain the struts 180a, 180b, 180c until the illumination device 110 delivered out of the catheter. In some embodiments, for example, the collapsed illumination device 110 self-expands to its enlarged cross-section under its own bias following delivery through an introducer.
The self-expanding device 110 can be made, in whole or in part, one or more shape memory materials, which can move the illumination device 110 between the collapsed and expanded configuration when activated. The shape memory material may include, for example, a shape memory alloy (e.g., NiTi), a shape memory polymer, ferromagnetic material, or other material. These materials can be transformed from a first preset configuration to a second preset configuration when activated. The shape memory material can be activated by an external energy source (e.g., an ultrasound energy source, thermal energy source, etc.), internal heating elements, and the like.
As noted above, various types of connections can permit actuation of the struts 180a, 180b, 180c. In some embodiments, including the illustrated embodiment of Figures 2A and 2B, an articulatable junction 200 connects the elongate struts 180a, 180b, 180c to the hub 182 and can comprise at least one shape memory material. After the collapsed illumination device 110 is positioned within the cavity 114, the junction 200 is activated to move the shape memory material to a preset or memorized shape to bias the elongated struts 180a, 180b, 180c towards their expanded configurations. Alternatively or additionally, the illumination device 110 may be expanded using any of a variety of expansion techniques involving enlargement structures (such as an inflatable balloon), mechanical expansion means (such as a pullwire assembly), and the like. It is contemplated that shape memory materials can be used in combination with these expansion techniques.
With continued reference to Figures 2A and 2B, the main body 112 can be used to steer and position the illumination device 110. To aim the illumination device 110 in situ, the main body 112 can translate and rotate the illumination device 110. The properties of the main body 112 can be selected to maintain angular displacement or bending at or below a desired level. Thus, the light delivery apparatus 100 can be readily rotated and translated in situ. The main body 112 can include one or more wires, electrical connectors, or circuitry to provide power to the light sources 140.
A controller 170 commands the array of light sources 140. Each of the light sources 140 can be selectively controlled to obtain a desired light field. The controller 170 can accurately control which light sources 140 are activated, the amount of power supplied to the light sources 140, and time period or sequence of activation. In some embodiments, the controller 170 includes a control input 171 and a power supply 173 (shown in phantom in Figure 2B) for powering the light sources 140. The control input 171 is used to select the amount of radiant energy emitted by the light sources 140. The illustrated power supply 173 is an internal battery, such as a lithium battery, that powers the light delivery apparatus 100. In other embodiments, the light delivery apparatus 100 is powered by an AC power source, such as an electrical outlet typically found at a hospital, medical facility, or other suitable location for performing light therapy. The controller 170 can include a power cord connectable to the AC power source. Accordingly, various types of internal and/or external power sources can power the light delivery apparatus 100.
The control input 171 can control the length, number, and/or intensity of the light stimulation cycles. The control input 171 can be a dial (e.g., an analog dial), but other types of input devices may be suitable for commanding the light delivery apparatus 100. The control input 171 can be a digital input device, for example. Thus, digital or analog input devices can be used. The controller 170 can have a closed loop system, whereby the power to the sources 140 is controlled based upon feedback signals from one or more sensors (e.g., a sensor 175 of Figure 1) configured to detect and transmit (or send) one or more signals indicative of temperature, pressure, or any other measurable parameters of interest. Based on those readings, the controller 170 can then adjust the output from the sources 140. Alternatively, the apparatus 100 can be an open loop system wherein the amount of stimulation produced by the light sources 140 is set by user input. For example, the sources 140 may be set to a fixed power mode by utilizing the control input 171. It is contemplated that the apparatus 100 can be switched between a closed and open loop system.
Sensors can be used to ensure proper treatment and prevent overheating. If the activated light sources 140 generate appreciable amounts of heat, the sensor 175 of Figure 1 can be a temperature sensor used to ensure that the temperature of the person's tissue is maintained at an acceptable level. In some embodiments, the sensor 175 can comprise, without limitation, one or more thermocouples, pyrometers, and the like. Other types of sensors can also be used.
Figures 3A and 3B show an introducer 210 of the treatment system 90 for placement in a hole or opening 220 in the abdominal wall 122 (see Figure 1). The introducer 210 has a main body 211 defining a delivery lumen 230 dimensioned to receive the light delivery apparatus 100. The lumen 230 extends between a proximal opening 232 and a distal opening 234.
A port 238 of the introducer 210 can be permanently or temporarily coupled to the line 150, as shown in Figure 1. The illustrated port 238 of Figure 3B extends outwardly from the main body 211. An insufflation lumen 237 extends through the port 238 and a portion of the main body 211. The illustrated lumen 237 extends between an inlet 239 and an outlet 241 adjacent the opening 234.
Various types of introducers can provide access to internal tissue. For example, introducers in the form of delivery sheaths or catheters, cannulas, ports, laparoscopic instruments (e.g., trocar cannulas), sleeves, or other types of access devices can be used. The introducers can be configured to extend through the abdominal wall 122 or other intermediate tissue while allowing for insufflation. Alternatively, the illumination device 110 can be delivered without using any introducers. For example, the illumination device 110 can be inserted directly through a hole (e.g., a hole formed using minimally invasive techniques, open surgical techniques, and the like) in the abdominal wall 122.
Figures 4-6 illustrate one embodiment of providing light therapy on the omentum 120. Generally, the illumination device 110 is advanced through the abdominal wall 122 via the introducer 210. The space 114 between the omentum 120 and abdominal wall 122 can be insufflated to accommodate the illumination device 110. After placing the light delivery apparatus 100 in the subject, the light sources 140 are activated to illuminate one or more target regions of the omentum 120. The illumination device 110 can then be removed and reused as desired.
As shown in Figure 4, the illumination device 110 can be manually inserted into the proximal opening 232 and then advanced distally through the delivery lumen 230. The user manually holds the illumination device 110 in the collapsed configuration. Because the illumination device 110 is collapsed, a relatively small hole 220 and introducer 210 can provide access to the internal cavity 114.
Before, during, and/or after insertion of the illumination device 110, the cavity 114 can be insufflated. The inflated cavity 114 of Figure 5 is filled with fluid F while the illumination device 110 is advanced distally (indicated by the arrow 250) through the delivery lumen 230.
To insufflate the cavity 114, the pressurization device 146 shown in Figure 5 delivers fluid F through the line 150 into the introducer 210. The fluid F flows through the introducer 210 into the cavity 114. The pressurization device 146 can accurately adjust the pressure of the fluid F to achieve the desired level of insufflation. Various types of fluids (e.g., gases, liquids, or gas/liquid mixtures) can be utilized. Exemplary non-limiting fluids include, without limitation, ambient air, water, transmission gels (e.g., light transmission gels) or agents, carbon dioxide, oxygen, combinations thereof, and other bio-compatible materials. The insufflation fluid can also contain one or more additives, such as treatment agents including, without limitation, antibiotics, light sensitive agents, medicaments, and the like.
The pressurization device 146 of Figure 5 can be a fluid storage container that contains pressurized fluid. A regulator can control the flow of fluid from the device 146. Alternatively or additionally, the pressurization device 146 can comprise at least one pump or other device suitable for pressurizing the fluid F. Other types of pressurization devices or systems can also be used.
After the illumination device 110 is positioned within the cavity 114, the device 110 self-expands to its enlarged expanded configuration. As shown in Figure 6, the light sources 140 are then activated to illuminate the target tissue 130. These light sources 140 can cooperate to emit a generally uniform field of light rays for a somewhat homogenous treatment of the target tissue such that a substantial portion or most of the emitted light illuminates the target tissue 130. To limit or substantially prevent direct illumination of the abdominal wall 122, the array of light sources 140 can be aimed at the omentum 120 during the entire illumination process, thus minimizing collateral damage to the abdominal wall 122.
In some embodiments, visualization techniques are used to view the position of the light delivery apparatus 100. Fluoroscopy (e.g., x-ray fluoroscopy), direct viewing (e.g., laparoscopes, endoscopes, and the like), CT machines, angiography, or other suitable visualization systems can provide viewing of the illumination device 110. In this manner, a physician can accurately determine the position of the illumination device 110 within the patient in real time.
One or more markers (e.g., radio-opaque markers) can be disposed along the light delivery apparatus 100. The number and position of the markers can be selected based on the treatment to be performed. The markers may be made from a material readily identified after insertion into a patient's body by using visualization techniques, such as the techniques noted above. If x-ray fluoroscopy is employed, the markers are preferably made from gold, tungsten, or any other readily identifiable material.
In some embodiments, a viewing element is coupled to the light delivery apparatus 100. The viewing element can be an optical fiber, camera, or other device that can capture images. During the therapy procedure, the illuminated tissue is viewable to ensure proper treatment. In some embodiments, the light delivery apparatus 100 is integrated with an endoscopic instrument, such as a laparoscope. In other embodiments, a viewing element can be provided on a separate delivery tool. For example, the light delivery apparatus 100 can be passed through a working lumen of an endoscope, which has a viewing element.
Figures 7 to 27 show embodiments of light delivery apparatuses that are generally similar to the light delivery apparatus 100 illustrated in Figures 1 to 6, except as further detailed below. Figures 7 to 10 show a light delivery apparatus
300 including a deployable illumination device 302 movable between a roll-upped configuration (Figures 7 and 8) for insertion and an unrolled, expanded configuration (Figure 9) for emitting light. An actuatable main body 312 extends between the illumination device 302 and a controller 326. The main body 312 can articulate the illumination device 302 between a low profile delivery position (Figure 7) and a deployment position (Figure 8) suitable for expanding the device 302. The illumination device 302 includes a flexible sheet 340 and an array of light sources 342 coupled to the sheet 340. The sheet 340 is made, in whole or in part, of an opaque material that inhibits or substantially prevents light emitted from the light sources 342 from passing therethrough. As shown in Figure 10, the light sources 342 are mounted to a distal face 352 of the sheet 340, and when activated, they emit light outwardly from the distal face 352. The opaque sheet 340 blocks the emitted light and therefore protects the tissue proximal to the sheet {e.g., the abdominal wall 122). Accordingly, the array of light sources 342 can be conveniently aimed at target tissue while limiting or minimizing collateral tissue damage. The sheet 340 can be formed of a polymer, metal, composite material, shape memory material, or combinations thereof, as well as other materials that are somewhat opaque. In other embodiments, the sheet 340 for emitting light in opposite directions may comprise one or more optically transparent materials. For example, the device 302 with a transparent sheet 340 may emit light in opposite directions (e.g., distally and proximally) to treat target tissue on opposing sides of a body cavity. Referring to Figures 11A and 11 B, the main body 312 includes a central body 350 and a mounting tip 354 rotatably mounted to a distal end 360 of the central body 350. In the illustrated embodiment, the mounting tip 354 is movable between a low profile position (Figure 11A) and a deployment position (Figure 11 B). When the illumination device 302 is unrestrained, the mounting tip 354 can rotate from the low profile position to the deployment position, as indicated by the arrow 366 of Figure 11 A. In some embodiments, as the illumination device 302 passes out of an introducer, the unrestrained mounting tip 354 rotates outwardly until it reaches its deployment position to allow the sheet 340 to expand into its deployed configuration, as shown in Figure 9.
When the mounting tip 354 is in the deployment position, the sheet 340 can easily expand by an unfurling process, without interference from the central body 350. The mounting tip 354 shown in Figure 11 B is generally perpendicular to the central body 350; however, other positions of the mounting tip 354 are also possible.
The main body 312 can comprise a shape memory material for self- deploying. For example, the main body 312 can comprise wire formed of shape memory material, such as NiTi, that is thermally activatable to move the mounting tip 354. In some non-limiting exemplary embodiments, the controller 326 operates a heating element that heats the main body 312 to the desired temperature for thermal activation of the shape memory material. Alternatively or additionally, the light sources 342, when activated, generate a sufficient amount of heat to cause thermal activation of the shape memory material.
The light sources 342 may be evenly or unevenly spaced along the sheet 340. The illustrated light sources 342 are somewhat evenly spaced from each other. To power the light sources 342, the illustrated light delivery apparatus 300 of Figure 7 includes a power source 370 electrically coupled to the light sources 342 by a lead 372 extending along next to a portion of the main body 312. In other embodiments, the lead 372 can extend through a lumen in the main body 312 to further reduce the profile of the apparatus 300. One of ordinary skill in the art can select the position and configuration of the lead 372 based on the procedure to be performed.
In operation, the illumination device 302 in the low profile configuration is delivered into a patient via an introducer. After the illumination device 302 is within the patient, the illumination device 302 can be rotated outwardly to the deployment position to allow the sheet 340 to then unfurl within the body cavity. For convenient and rapid expansion, the sheet 340 can be self- expanding. After the light sources 342 illuminate target tissue, the sheet 340 can be rolled-up and returned to its pre-deployment configuration. The mounting tip 354 is then rotated from the deployment position to the low profile position for convenient removal.
The illustrated sheet 340 of Figure 9 has a generally polygonal shape (illustrated as a quadrilateral parallelogram), as viewed from above. However, the sheet 340 can have other configurations. Figure 12A illustrates a generally circular sheet 400. Figure 12B illustrates a generally triangular sheet 402. Figure 12C illustrates a generally hexagonal sheet 406. Figure 12D illustrates a sheet 407 having a combination of linear and arcuate sides. These sheets can also have uniform or varying thicknesses so long as they can be suitably positioned within the patient.
Figures 13 and 14 show an illumination device 420 that is generally similar to the illumination device 302 of Figures 7-11 B, except as detailed below. The illustrated illumination device 420 has a folded, collapsed configuration (Figure 13) and an unfolded, expanded configuration (Figure 14), and includes an illumination device body 430 and an array of light sources 440 coupled to the illumination device body 430. The illumination device body 430 includes a plurality of elongate panels hingedly coupled together to form a foldable sheet. When the illumination device 420 is in the expanded configuration, adjacent panels can be angled to each other, as shown in Figure 14, or the expanded illumination device 420 can be generally flat. The illumination device 420 can be folded and unfolded any number of times to perform any desired number of treatments.
Figures 15-17 show an illumination device 500 having an actuatable sheet holder 510 mounted to a main body 518. The actuatable sheet holder 510 can be actuated to move a pair of sheets 522, 524 between a collapsed configuration (Figure 15) and an expanded configuration (Figure 17). A plurality of outwardly deployable legs 530a, 530b, 530c, 53Od of the holder 510 are rotatably mounted to a hub 540, which is fixedly coupled to the main body 518.
The distal ends of the legs 530b, 530c are coupled to opposing sides of the sheet 522. Similarly, the distal ends of the legs 530a, 53Od are coupled to opposing sides of the sheet 524. The distal ends of the legs 530a-d are moved outwardly to unfold the sheets 522, 524 such that the generally flat expanded sheets 522, 524 are positioned next to each other and generally perpendicular to a longitudinal axis 525 of the main body 518, as shown in Figure 17.
Figures 18-20 illustrate a manually deployable light delivery apparatus 600 that includes a deployment control assembly 610, an illumination device 616, and a main body 620 extending therebetween. Generally, the control assembly 610 includes a plunger 640 and a pair of control elements 644a, b. The plunger 640 is depressed linearly to rotate the illumination device 616 from a low profile delivery position (Figure 18) to a deployment position (Figure 19). The control elements 644a, b are then used to move the illumination device 616 into an expanded configuration (Figure 20). As shown in Figures 20 to 22, an actuating system 660 is formed by a distal end 670 of the plunger 640 and a coupling member 680 fixedly coupled to flexible elongated members 690a, b. A pin 692 can pivotally couple the distal end 670 to the coupling member 680 such that, when the plunger 640 is depressed, the distal end 670 pushes the member 680 thereby causing rotation of the flexible elongated members 690a, b (indicated by the arrow 691 of Figure 21). The plunger 640 can also be pulled proximally to return the illumination device 616 to the low profile position. In this manner, the illumination device 616 can be repeatedly actuated between the low profile and deployment positions.
With reference again to Figures 19 and 20, the control elements 644a, b are fixedly coupled to the elongate members 690a, b, respectively, and rotatably disposed within the main body 620. Once the unexpanded illumination device 616 is in the deployment position, the control elements 644a, b can be rotated towards each other (indicated by the arrows 700, 702 of Figure 19) to correspondingly rotate the elongate members 690a, b outwardly (indicated by the arrows 703, 705 of Figure 20) causing the furled illumination device 616 to unfurl from the elongate members 690a, b.
The light sources 693 coupled to the sheet 641 can then be activated to perform light therapy. After treatment, the unfurled illumination device 616 can be furled once again about the elongated members 690a, b. The furled illumination device 616 can be returned to the low profile position for subsequent removal from the subject.
Figures 23-26 illustrate a manually deployable light delivery apparatus 730. The light delivery apparatus 730 includes an actuating system 740 having a plunger 742 slidably retained in a main body 744. A deployable illumination device 750 is coupled to the main body 744. To move the illumination device 750 from a collapsed position (Figure 23) to an expanded configuration (Figure 24), the plunger 742 can be pulled proximally to cause central portions of straight, flexible struts 760 to bulge outwardly away from a longitudinal axis 763 of the illumination device 750. The proximal ends of the struts 760 are coupled to the main body 744, and the distal ends of the struts 760 are coupled to a distal end 794 of the plunger 742.
One or more light sources 780 can be coupled to each of the struts 760. When the illumination device 750 is in the deployed configuration, the light sources 780 can be directed distally such that, when activated, light rays are emitted distally, thereby protecting tissue positioned proximal to the illumination device 750.
With continued reference to Figures 23 and 24, the plunger 742 includes an engagement portion 790 and a plunger body 792. A handle 798 on the main body 744 is provided for convenient leveraging of the plunger 742.
In operation, the collapsed illumination device 750 can be inserted through an opening 800 in an abdominal wall 810, as shown in Figure 26. After the illumination device 750 is positioned within a space 812, the actuating system 740 is operated to expand the illumination device 750. Once expanded, the light sources 780 are activated to illuminate the target site 820 positioned in front of the illumination device 750, thereby protecting the abdominal wall 810 from the emitted light. Of course, if treatment of the abdominal wall 810 is desired, one or more light sources can be coupled to the proximal portions of the struts 760 facing the abdominal wall 810.
Figure 27 shows a treatment system 900 that includes a selectively deployable inflatable member 902 that surrounds an illumination device 906 of a light delivery apparatus 910. The device 906 can be similar to the illumination devices described above in connection with Figures 1 to 26. The illustrated inflatable member 902 can be inflated from a low profile, deflated configuration to an inflated configuration (as shown) and can transmit light emitted from the illumination device 906 to the omentum 120.
The inflatable member 902 includes a main inflation body 920 for surrounding the device 906 and a proximal portion 922 for engaging the subject. The main inflation body 920 can be made of any thin, flexible material, such as silicone, polyurethane, latex (e.g., natural or synthetic latex), or other materials that are used for pressure balloons, for example. The material type and wall thickness of the member 902 can be selected based on the desired inflation pressure, inflation size, and optical properties. In one embodiment, the flexible inflatable member 902 comprises a somewhat transparent compliant material, preferably an optically transparent polyester. At least one wavelength of light emitted by the illumination device 906 can pass through the inflatable member 902.
Suitable transmissive materials for forming the inflatable member 902 include, but are not limited to, polymers such as polyester, PET, polypropylene, combinations thereof, and the like. In some embodiments, at least 40% of the light emitted towards the inflatable member 902 is transmitted therethrough. In some embodiments, at least 50% of the light emitted towards the inflatable member 902 is transmitted therethrough. In other embodiments, at least 60% of the light emitted towards the inflatable member 902 is transmitted therethrough. In yet other embodiments, at least 70% of the light directed towards the inflatable member 902 is transmitted therethrough. In some other embodiments, at least 80% of the light directed towards the inflatable member 902 is transmitted therethrough. In still other embodiments, at least 90% of the light directed towards the inflatable member 902 is transmitted therethrough. Additionally, one or more light passageways, through-holes, windows, or other structures can be formed in the inflatable member 902 to increase the amount of light passing through the inflatable member 902.
The inflatable member 902 can optionally include one or more opaque materials that can inhibit or prevent one or more wavelengths or wavebands from passing therethrough. Opacification agents, additives, coatings, or combinations thereof can be utilized to render the inflatable member 902 (or portion thereof) somewhat opaque. Opacification agents can include, but are not limited to, dyes, pigments, metal particulates or powder, or other materials that can be coated onto, disbursed throughout, or otherwise disposed in a wall 927 of the inflatable member 902. If desired, the inflatable member 902 can function as a filter so as to inhibit or prevent one or more wavelengths or wavebands from reaching the patient's tissue.
To inflate the inflatable member 902, an inflation fluid (e.g., a gas, liquid, or gas/liquid mixture) can fill a chamber 930 until the inflatable member 902 reaches a desired inflated configuration. The inflatable member 902 can be controllable inflated using the techniques, fluids, and devices described above. For example, a pressurization device can accurately adjust the pressure of an inflation fluid to achieve the desired level of inflation. Exemplary non-limiting fluids include, without limitation, ambient air, saline, water, transmission gels {e.g., light transmission gels) or agents, carbon dioxide, oxygen, insufflation fluid, combinations thereof, and other bio-compatible materials.
The illustrated treatment system 900 is used to enlarged the cavity 114 without using an insufflating system. That is, the inflatable member 902 itself causes enlargement or expansion of the cavity 114 by physically contacting and pushing against the patient's tissue. In alternative embodiments, an insufflating system (such as the insufflating system 141 of Figure 1) can be used to insufflate the cavity 114 before, during, or after placement of the inflatable member 902. In yet other embodiments, the cavity 114 is not enlarged or expanded during treatment. For example, the system 900 can be used in natural anatomical cavities that accommodate the system 900 without disturbing the patient's tissue. A catheter 944 shown in Figure 27 can have an inflation lumen for delivering fluid into the inflatable member 902 via an outlet port 940. The deflated inflation member 902 can be easily inserted through the abdominal wall 122 into the cavity 114. Once positioned in the cavity 114, the inflatable member 902 can be enlarged from the deflated configuration to a partially or fully inflated configuration by fluid flowing out of the outlet port 940. Because the inflatable member 902 defines a large internal chamber 943, the illumination device 906 can be freely expanded without striking the patient.
During and/or after deployment, the illumination device 906 can emit light to treat the target tissue. The light travels through the inflation fluid, through the wall 927 of the inflatable member 902, and to the omentum 120. During this process, the inflatable member 902 can rest against the target tissue. The inflatable member 902 may be sufficiently compliant to conform to the shape to the omentum 120 without injuring or significantly traumatizing the tissue while ensuring efficient light transmission to the target tissue of interest. In other embodiments, the inflatable member 902 can be distanced from the target tissue, or any other tissue during the light delivery process, to prevent trauma to internal tissue. The exterior of the inflatable member 902 can have any desired shape or contour based on the procedure to be performed.
The inflation member 902 can be fixedly coupled to the catheter 944 such that the illumination device 906 is permanently fixed relative to the inflation member 902. In other embodiments, the inflation member 902 can be movable with respect to the catheter 944. For example, the inflation member 902 can be slidably coupled to the catheter 944 to permit movement of the illumination device 906 through the inflation member 902 for improved maneuverability. Various types of mounting arrangements can be used to movably couple the proximal end 922 of the member 902 to the catheter 944. The proximal end 922 of the inflation member 902 can engage the abdominal wall 122. A seal (e.g., a hermetic seal) may be formed between the proximal end 922 and wall 122 to limit, minimize, or substantially prevent any fluid from escaped out of the cavity 114, especially if pressurized fluid is in the cavity 114. Sealing members, compliant rings, or other sealing components can provide the desired interaction between the proximal end 922 and wall 122.
Advantageously, the inflatable member 902 can define an outer atraumatic surface that minimizes, limits, or substantially eliminates trauma to the patient. For example, the wall of the inflatable member 902 serves as a protective barrier between the illumination device 906 and the patient to reduce the likelihood of trauma to the patient allowing the illumination device 906 to be freely maneuvered within the cavity 114 without an appreciable risk of injuring the patient.
After delivering light therapy, the inflatable member 902 can be deflated for subsequent removal from the patient. The illumination device 906 and inflatable member 902 can be collapsed sequentially or simultaneously. The inflatable member 902 can be used to perform another procedure or discarded. All of the above U.S. patents, U.S. patent application publications, U.S. patent applications, foreign patents, foreign patent applications and non- patent publications referred to in this specification and/or listed in the Application Data Sheet, to include U.S. Patent Nos. 6,958,498; 6,784,460; 6,661 ,167; and 6,445,011 ; U.S. Publication Nos. 2005/0228260 and 2005/0085455; International Patent Application Nos. PCT/US2005/032851 and PCT/US01/44046; and U.S. Provisional Patent Application No. 60/640,382, are incorporated herein by reference, in their entireties. Except as described herein, the embodiments, features, systems, devices, materials, methods and techniques described herein may, in some embodiments, be similar to any one or more of the embodiments, features, systems, devices, materials, methods and techniques described in the incorporated references. In addition, the embodiments, features, systems, devices, materials, methods and techniques described herein may, in certain embodiments, be applied to or used in connection with any one or more of the embodiments, features, systems, devices, materials, methods and techniques disclosed in the above-mentioned incorporated references.
The various methods and techniques described above provide a number of ways to carryout the invention. Of course, it is to be understood that not necessarily all objectives or advantages described may be achieved in accordance with any particular embodiment described herein. Thus, for example, those skilled in the art will recognize that the methods may be performed in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other objectives or advantages as may be taught or suggested herein.
Furthermore, the skilled artisan will recognize the interchangeability of various features from different embodiments disclosed herein. Similarly, the various features and acts discussed above, as well as other known equivalents for each such feature or act, can be mixed and matched by one of ordinary skill in this art to perform methods in accordance with principles described herein. Additionally, the methods which are described and illustrated herein are not limited to the exact sequence of acts described, nor are they necessarily limited to the practice of all of the acts set forth. Other sequences of events or acts, or less than all of the events, or simultaneous occurrence of the events, may be utilized in practicing the disclosed embodiments.
Although the invention has been disclosed in the context of certain embodiments and examples, it will be understood by those skilled in the art that the invention extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses and obvious modifications and equivalents thereof. The materials, methods, ranges, and embodiments disclosed herein are given by way of example only and are not intended to limit the scope of the disclosure in any way. Accordingly, the invention is not intended to be limited by the specific disclosures of preferred embodiments disclosed herein.

Claims

CLAIMSWhat is claimed is:
1. A light delivery apparatus for performing light therapy on a subject, the apparatus comprising: a deployable illumination device having a plurality of light sources capable of emitting light that activates a therapeutically effective amount of a treatment agent in target tissue of the subject, the illumination device movable from a collapsed configuration to an expanded configuration so as to spread the plurality of light sources outwardly while the illumination device is positioned within a space in the subject; and an elongate main body coupled to the illumination device, the elongate main body configured to carry the illumination device into the subject to an internal location at least near the target tissue.
2. The light delivery apparatus of claim 1 , wherein the deployable illumination device comprises a plurality of elongate struts, the elongate struts movable between a substantially straight configuration when the illumination device is in the collapsed configuration and an outwardly bowed configuration when the illumination device is in the expanded configuration, and each of the elongate struts carries at least one light source.
3. The light delivery apparatus of claim 1 , wherein the deployable illumination device comprises a sheet assembly carrying the plurality of light sources, the sheet assembly including a plurality of hinges that move as the sheet assembly moves between a folded position and an unfolded position.
4. The light delivery apparatus of claim 3, wherein the sheet assembly is generally flat when in the unfolded position.
5. The light delivery apparatus of claim 3, further comprising: an actuable sheet holder having deployable arms coupled to opposing sections of the sheet assembly, the deployable arms move the sheet assembly between the folded position and the unfolded position when the arms are moved outwardly from one another.
6. The light delivery apparatus of claim 1 , wherein the deployable illumination device comprises a sheet to which the plurality of light sources are coupled, the sheet is in a furled state when the illumination device is in the collapsed configuration and an unfurled state when the illumination device is in the expanded configuration.
7. The light delivery apparatus of claim 1 , wherein the deployable illumination device comprises shape memory material that moves the illumination device between the collapsed configuration and the expanded configuration when the shape memory material is activated.
8. The light delivery apparatus of claim 1 , further comprising: a selectively inflatable member that surrounds and accommodates the illumination device while the inflatable member is in the space of the subject and the illumination device is in the collapsed configuration and the expanded configuration, the selectively inflatable member is adapted to transmit light emitted from the illumination device.
9. The light delivery apparatus of claim 8, wherein, when the inflatable member is at least partially inflated, the illumination device within an interior chamber of the inflatable member is permitted to freely expand between the collapsed configuration and the expanded configuration.
10. The light delivery apparatus of claim 8, wherein the selectively inflatable member is a compliant balloon.
11. A light delivery apparatus for treating a subject, the apparatus comprising: a main body adapted to access an internal target site in the subject; and a light emitting tip coupled to the main body, the light emitting tip movable between a low profile configuration and an expanded illumination configuration, the light emitting tip having at least one light source movable with respect to the main body, the at least one light source moves into an illumination position for illuminating the target site as the light emitting tip is moved from the low profile configuration to the illumination configuration.
12. The light delivery apparatus of claim 11 , wherein the light emitting tip is adapted to self-expand from the low profile configuration to the expanded illumination configuration.
13. The light delivery apparatus of claim 11 , further comprising: an external power source in electrical communication with the at least one light source via the main body, the main body is long enough to extend from the power source positioned external to the subject to a cavity adjacent the target site.
14. A method of treating target tissue of a subject, the method comprising: advancing an illumination device into the subject, the illumination device having at least one light source adapted to emit light capable of activating a treatment agent in the target tissue; insufflating a space between a first layer of tissue and a second layer of tissue of the subject; positioning the illumination device in the insufflated space; and illuminating the first layer of tissue with light from the at least one light source.
15. The method of claim 14, wherein most of the light emitted from the illumination device is directed towards the first layer of tissue, the first layer of tissue is the omentum and the second layer of tissue is the abdominal wall.
16. The method of claim 14, further comprising: moving the illumination device from a collapsed configuration to an expanded configuration while the illumination device is in the insufflated space.
17. The method of claim 16, wherein the at least one light source comprises an array of light sources that are deployed outwardly as the illumination device moves from the collapsed configuration to the expanded configuration.
18. The method of claim 14, wherein the illumination device is spaced from the first layer of tissue and the second layer of tissue during the illumination of the first layer of tissue.
19. The method of claim 14, further comprising: self-expanding the illumination device from a collapsed configuration to an expanded configuration while the illumination device is in situ.
20. The method of claim 14, further comprising: passing the illumination device through the second layer towards the first layer of tissue while the illumination device is in the collapsed configuration.
21. The method of claim 14, further comprising: positioning an introducer into the first layer of tissue; and moving the illumination device through a passage of the introducer into the insufflated space.
22. A light delivery apparatus for treating a subject, the apparatus comprising: an illumination device dimensioned for placement in a body cavity of the subject, the illumination device having a first preset configuration for delivery into the body cavity and a second preset configuration for illuminating tissue; and a plurality of light sources coupled to the illumination device, wherein the plurality of light sources becomes exposed when the device moves from the first configuration to the second configuration.
23. The light delivery apparatus of claim 22, wherein, when the plurality of light sources are exposed and activated, the plurality of light sources cooperate to emit a substantially uniform field of light rays.
24. The light delivery apparatus of claim 22, wherein the plurality of light sources are longitudinally arranged when the illumination device is in the first preset configuration, and the plurality of light sources are laterally arranged when the illumination device is in the second preset configuration.
25. A light delivery apparatus for treating a subject, the apparatus comprising: an elongate main body for advancing through the subject; and an illumination device coupled to a distal end of the elongate main body and dimensioned for placement in a cavity in the subject, the illumination device having a first configuration and a second configuration and comprising a plurality of light sources, wherein an outermost pair of the light sources defines a first transverse width when the illumination device is in the first configuration and an outermost pair of the light sources defines a second transverse width greater than the first transverse width when the illumination device is in the second configuration.
26. The light delivery apparatus of claim 25, wherein the illumination device has a long axis, and the light sources are moved away from the long axis as the illumination device moves from the first configuration towards the second configuration.
27. A light delivery system for treating a subject, the apparatus comprising: a deployable illumination device having a plurality of light sources movable with respect to one another as the illumination device is mechanically deployed; and an inflatable member housing the deployable illumination device and capable of transmitting a sufficient amount of light emitted by the plurality of light sources such that a therapeutically effective amount of a treatment agent in target tissue is activated by the emitted light.
28. The light delivery system of claim 27, wherein the inflatable member is a compliant balloon having a collapsible configuration and an inflated configuration, and the deployable illumination device is movable between a low profile collapsed configuration and an expanded configuration when the inflatable member is in the inflated configuration.
29. A light delivery system for performing light therapy on a subject, the system comprising: an introducer adapted for placement in an opening in tissue of the subject; an deployable illumination device having a plurality of light sources capable of emitting light, the illumination device movable from a collapsed configuration to an expanded configuration to move the plurality of light sources into a deployed arrangement, wherein the illumination device, in the collapsed configuration, has a first transverse width and the illumination device, in the expanded configuration, has a second transverse width substantially greater than the first transverse width; and an elongate main body coupled to the illumination device, the elongate main body configured to carry the illumination device along a lumen of the introducer into a space adjacent target tissue of the subject.
30. The light delivery system of claim 29, wherein the illumination device has a long axis, and the light sources are moved away from the long axis as the illumination device moves from the collapsed configuration towards the expanded configuration.
31. The light delivery system of claim 29, further comprising: an insufflating system including a pressurization device and a fluid line coupled to the pressurization device to provide fluid communication between the space and the pressurization device, the pressurization device is adapted to insufflate the space when activated.
PCT/US2007/081147 2006-10-11 2007-10-11 Light delivery apparatus and methods for illuminating internal tissues WO2008046019A1 (en)

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